Pharmaceutical Calculations [Hardcover]

Mitchell J. Stoklosa

(Author), Howard C. Ansel (Author)

Editorial Reviews

Product DescriptionMassachusetts College of Pharmacy and Allied Health Sciences, Boston, Massachusetts. Tenth edition of a major textbook for pharmacy students. Previous edition 1991. In conformance with the U.S. Pharmacopeia, uses the metric system instead of the apothecaries' system. Conversion charts appear in the appendix.

Product Details

Hardcover: 361 pages Publisher: Williams & Wilkins; 10 Sub edition (January 15, 1996) Language: English ISBN-10: 0683080016 ISBN-13: 978-0683080018 Product Dimensions: 9.9 x 6.8 x 1.2 inches Shipping Weight: 2 pounds

B001IGHLSE

B001IGHLTS

Pharmaceutical Calculations [Hardcover]

Howard C. Ansel (Author), Mitchell J. Stoklosa (Author)

 Editorial Reviews

Product Description

The gold standard textbook in its area for sixty years,Pharmaceutical Calculations is now in its Twelfth Edition. Every chapter has been revised and updated to reflect the basic calculations applicable to the contemporary practice of pharmacy.

This edition provides expanded coverage of enteral and parenteral nutrition. New features include "Calculations Capsules"--boxed summaries of the type of calculation presented in each chapter, and "A Case in Point"--practical cases with step-by-step solutions to demonstrate each type of calculation.

Review exercises at the end of the book are completely updated. This edition includes answers to all practice and review problems.

Product Details

Hardcover: 464 pages Publisher: Lippincott Williams & Wilkins; Twelfth edition (December 30, 2005) Language: English ISBN-10: 0781762650 ISBN-13: 978-0781762656 Product Dimensions: 10.2 x 7.1 x 0.8 inches

B001IGHLTS

Cleanroom Technology: Fundamentals of Design, Testing and Operation [Hardcover]

William Whyte (Author)

Editorial Reviews

Review"...extremely useful and helpful...very well-written, highly organized, easy to understand and follow..." (Environmental Geology, 2003)

Product DescriptionA cleanroom is a contamination-controlled environment and is essential in the industrial manufacture of many electronic, semiconductor, optical, pharmaceutical and medical products. The use of cleanrooms for the manufacture of a large range of products such as microprocessors, CD players, lasers, pharmaceuticals and medical devices continues to grow and many companies are using cleanrooms for the first time. At the same time, new technology products that can only be produced in cleanrooms are being developed. This comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems provides novices with a introduction to this state-of-the-art technology and professionals with an accessible reference to the current standards. Readers will benifit from the author's 35 years of experience in cleanroom technology R&D, consultancy and teaching. The text is complementary to the structure and content of Whyte's own and many in-house cleanroom courses in the electronics and pharmaceutical industries. · Complementary to the highly successful Cleanroom Design, Second Edition and the forthcoming Cleanroom Testing and Running by the same author · Presents the fundamentals and latest standards for the design, validation, testing and running of cleanroom systems Pitched at introductory level and tailored to fulfil the training requirements of scientists and engineers new to cleanroom technology See all Editorial Reviews

Product Details

Hardcover: 320 pages Publisher: Wiley (September 12, 2001) Language: English ISBN-10: 0471868426 ISBN-13: 978-0471868422 Product Dimensions: 9.1 x 6.1 x 0.9 inches

SOP Guidelines D. H. Shah (Author)

 Editorial Reviews

Product DescriptionIntroducing the Second Edition of our bestselling book, the new edition is now a comprehensive and cutting-edge guide to preparation and management of Standard Operating Procedures. It covers the fields of Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping. Contains actual full text SOPs that can be inorporated directly in your systems and modified as required. It includes for the first time, detailed and easy to understand methods of developing SOPs that are required by the manufacturer and regulatory agencies. Electronic SOP management systems and their desired structures are covered. Also included in the new edition are various systems of Electronic Batch Records and pharmaceutical ERP systems and their management. CONTENTS Introduction Preface to the1st Edition DESIGNING EFFECTIVE SOPs Introduction and Purpose of SOPs Benefits of SOPs Types of SOPs Contents of a Typical SOP Level of Detail Writing Style SOP Development Create/Edit Review Approve Publish Distribute Archive SOP Format Title Page Table of Contents Text Transition to Electronic SOPs Too Many Documents Over-complex Documents Inappropriate Format Management Systems Advantages of Electronic SOPs System Requirements Structure of eSOP System Audit Critical Activities Authenticate Users Keep Track of Who Has Seen What Validation Support Future of eSOP ELECTRONIC MANUFACTURING eMANUFACTURING Understanding the e in the eManufacturing Electronic Records Requirements for Electronic Records Risk Based Approach to Future Purpose of eManufacturing Introduction to Electronic Batch Records (EBR) Benefits of Electronic Batch Records (EBR) Plant Efficiencies Impact of QC Lab on Batch Cycle Time Management of Manufacturing Data User Requirement Specification (URS) Vendor Selection Qualification and Validation of Software Evolution from Paper to EBR Features of cGMP Compliant EBR System Process Historian for Management of Manufacturing Data Enterprise Resource Plan

About the AuthorD. H. Shah graduated in pharmacy in 1962 and in the last 40 years has been actively associated with manufacture of all categories of drug formulations. He is presently Technical Director with a few reputed pharmaceutical companies and is involved in quality assurance and GMP compliance activities. --This text refers to an out of print or unavailable edition of this title.

Product Details

Hardcover: 464 pages Publisher: Business Horizons; 2nd edition (November 15, 2006) Language: English ISBN-10: 8190078887 ISBN-13: 978-8190078887 Product Dimensions: 9.6 x 7.4 x 1.3 inches

Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook [Hardcover]

Phil Cloud (Author)

Editorial Reviews

Product DescriptionWhile FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Product Details

Hardcover: 456 pages Publisher: Informa Healthcare; 1 edition (August 31, 1998) Language: English ISBN-10: 1574910795 ISBN-13: 978-1574910797

HPLC : Quantitative Analysis of Pharmaceutical FormulationsP.D. Sethi (Author)

Editorial Reviews

Product Description1 cardiovascular system. 2 musculoskeletal disorders. 3 antibiotics. 4 central nervous system. 5 alimentary system. 6 respiratory system and antiallergics. 7 preparations for external use. 8 vitamins and miscellaneous.

About the AuthorDr.P.D. Sethi obtained his Ph.D. from madras university, Madras, India. He has been pursuning his analytical career since last 30 years. All the books authored by him are on practical application of different analytical techniques for analysis of multi-component drug formulations. these books are the only kind on the subject. while serving as chairman, ayurvedic pharmacopoeia of india, Dr. Sethi was instrumental in adopting TLC for finger-print profiling of medicinal plants for their correct identification. it is often said that library of any analytical laboratory, pharmaceutical institute and pharma industry is incomplete without books authored by Dr. Sethi.

Product Details

Hardcover: 900 pages Publisher: CBS Publishers & Distributors (February 15, 2007) Language: English ISBN-10: 8123913788 ISBN-13: 978-8123913780

Validation of Pharmaceutical Processes, 3rd Edition [Hardcover]

James P. Agalloco (Editor), Frederick J. Carleton (Editor)

Editorial Reviews

Product DescriptionCompletely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.

Presenting theoretical knowledge and applied practical considerations, this title

provides an in-depth discussion of recent advances in sterilization

identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions

explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results

blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

Product Details

Hardcover: 760 pages Publisher: Informa Healthcare; 3rd edition (September 25, 2007) Language: English ISBN-10: 0849370558 ISBN-13: 978-0849370557

Pharmaceutical Product Development [Hardcover]

N.K. Jain (Editor)

Editorial Reviews

Product DescriptionCovers subjects such as oral liquids, tablets, parental products, packaging, and others which are contributed by pharmacists associated with Indian organizations and laboratories as well as universities.

Product Details

Hardcover Publisher: CBS Publishers & Distributors (February 15, 2007) ISBN-10: 8123913214 ISBN-13: 978-8123913216

Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Patkage Integrity Testing (Drugs and the Pharmaceutical Sciences) [Hardcover]

Michael K. Akers (Author), Dan Larrimore (Author), Dana Guazzo (Author)

Editorial Reviews

Product DescriptionBaxter Pharmaceutical Solutions, Bloomington, IN. Text describes the recent advances in the validation and execution of testing schemes for parenteral control. Emphasizes testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. Previous edition: c1993.

Product Details

Hardcover: 408 pages Publisher: Informa Healthcare; 3 edition (November 20, 2002) Language: English ISBN-10: 0824708857 ISBN-13: 978-0824708856 Product Dimensions: 9 x 5.9 x 1 inches

Pharmaceutical Water: System Design, Operation, and Validation [Hardcover]

William V. Collentro (Author)

Editorial Reviews

Product DescriptionFrom chemical and biological purity requirements, to system design and its impact on water purity, to the requirements and restrictions imposed by the regulators, this book comprehensively covers the unique water requirements of the pharmaceutical and biotechnology industries. Beginning with a brief overview of the theory and application of the technology, William Collentro clarifies the seemingly overwhelming engineering aspects as he discusses design considerations, operation, maintenance, validation, and regulatory-related topics bases upon personal experience with more than 400 pharmaceutical and related water purification systems. His extensive field experience and the numerous case studies recounted in this book ensure that all relevant aspects of pharmaceutical water technology are thoroughly explained in a clear, concise style.Features

Product Details

Hardcover: 694 pages Publisher: Informa Healthcare; 1 edition (September 30, 1998) Language: English ISBN-10: 1574910272 ISBN-13: 978-1574910278 Product Dimensions: 10.1 x 7.6 x 2 inches

B001K8DGJS

Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set) [Hardcover]

Sarfaraz K. Niazi (Author)

Editorial Reviews

Product Description

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development. Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

cGMP compliance pre-approval inspections stability and bioequivalence testing packaging commodity development common difficulties in formulating drugs

changes to aNDAs

Product Details

Hardcover: 2094 pages Publisher: Informa Healthcare; 2 edition (September 21, 2009) Language: English ISBN-10: 1420081063 ISBN-13: 978-1420081060 Product Dimensions: 16.4 x 12.3 x 8.5 inches

Handbook of Pharmaceutical Excipients (Rowe, Handbook of Pharmaceutical Excipients) [Hardcover]

Raymond C. Rowe (Editor), Paul J. Sheskey (Editor), Marian E. Quinn (Editor)

Editorial Reviews

Product Description"The Handbook of Pharmaceutical Excipients" is internationally recognised as the authoritative source of information on pharmaceutical excipients. "The Handbook of Pharmaceutical Excipients" is a comprehensive guide to the uses, properties and safety of pharmaceutical excipients and is an essential reference for those involved in the development, production, control or regulation of pharmaceutical preparations. The handbook collects together essential data on the physical properties of excipients as well as providing information on their safe use and potential toxicity. All monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.

About the AuthorRaymond Rowe and Paul Sheskey are both editors of the previous edition. Rowe in particular is widely recognised internationally as an expert on pharmaceutical excipients

Product Details

Hardcover: 888 pages Publisher: Pharmaceutical Press; 6 edition (July 31, 2009) Language: English ISBN-10: 0853697922 ISBN-13: 978-0853697923 Product Dimensions: 11 x 8.8 x 1.5 inches

Microbial Contamination Control in Parenteral Manufacturing (Drugs and the Pharmaceutical Sciences) [Hardcover]

Kevin Williams (Author)

Editorial Reviews

Review…will be welcomed by all involved in parenteral manufacturing….the value of this book is much more than as a guide to contamination control; it is the setting of each chapter within a wider and engaging context that makes this publication unique.-European Journal of Parenteral and Pharmaceutical Sciences

be welcomed by all involved in parenteral manufacturing….the value of this book is much more than as a guide to contamination control; it is the setting of each chapter within a wider and engaging context that makes this publication unique.-European Journal of Parenteral and Pharmaceutical Sciences

Product DescriptionThis reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

Product Details

Hardcover: 760 pages Publisher: Informa Healthcare; 1 edition (May 20, 2004) Language: English ISBN-10: 0824753208 ISBN-13: 978-0824753207

Product Dimensions: 9 x 6.2 x 1.6 inches

Quantitative Analysis of Drugs in Pharmaceutical Formulations [Hardcover]

P.D. Sethi (Author)

Editorial Reviews

Product Description1 introduction. 2 general requirements, quality assurance and accreditation of calibration/testing laboratories. 3 good laboratory practices. 4 analytical procedures and analyst validation. 5 profile of a quality control laboratory for pharmaceutical units. 6 analgesices and antipyretics. 7 alimentary drugs. 8 antibiotics. 9 anti-inflammatory drugs. 10 bronchospasm relaxants(anti-asthma). 11 cardiovascular drugs. 12 expectorants and cough suppressants. 13 eye, ear, nasal, preparations. 14 keratolytics and cleansers. 15 rubefacients. 16 sedatives and tranquillisers. 17 topical antifungal and anti-infective preparations. 18 vitamins, minerals and digestive enzyme preparation.

About the AuthorDr.P.D. Sethi obtained his Ph.D. from madras university, Madras, India. He has been pursuning his analytical career since last 30 years. All the books authored by him are on practical application of different analytical techniques for analysis of multi-component drug formulations. these books are the only kind on the subject. while serving as chairman, ayurvedic pharmacopoeia of india, Dr. Sethi was instrumental in adopting TLC for finger-print profiling of medicinal plants for their correct identification. it is often said that library of any analytical laboratory, pharmaceutical institute and pharma industry is incomplete without books authored by Dr. Sethi.

Product Details

Hardcover: 692 pages Publisher: CBS Publishers & Distributors; 3rd edition (January 1, 2008) Language: English ISBN-10: 8123905602 ISBN-13: 978-8123905600

Product Dimensions: 9.6 x 7.4 x 1.7 inches

Good Manufacturing Practices for

Pharmaceuticals: A Plan for Total Quality Control from Manufacturer (Drugs and the Pharmaceutical Sciences) [Hardcover]

Sidney Willig (Editor)

Editorial Reviews

Review"...an invaluable resource." -- Unlisted Drugs

"I am pleased to add this edition to my bookshelf!" -- European Journal of Pharmaceutics and Biopharmaceutics

"…an invaluable text….help[s] any individual or student learn the application of the CGMPs." -- Pharmaceutical Research

"…excellent in presentation and language….a value to anyone interested in drug manufacture." -- American Journal of Pharmaceutical Education

Product DescriptionTemple Univ., Philadelphia, PA. Examines United States law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. Recommends pragmatic ways to interpret and comply with FDA Current Good Manufacturing Practice regulation and related criteria. Previous edition: c1997.

Product Details

Hardcover: 732 pages Publisher: Informa Healthcare; 5th edition (November 15, 2000) Language: English ISBN-10: 0824704258 ISBN-13: 978-0824704254 Product Dimensions: 9.1 x 6.3 x 1.6 inches

Quality Rules in Packaging [Paperback]

John Sharp (Author)

Editorial Reviews

Product DescriptionThis newly-revised and specifically American edition of the best-selling original is the perfect introduction to drug packaging Good Manufacturing Practice (GMP). It is the ideal training resource for workers recently hired into the pharmaceutical, chemical, biotechnology, and bulk pharmaceutical industries. The central tool for many corporations' introductory training, retraining, and reinforcement programs, it covers all the drug packaging GMP concepts required by the US FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author explaining the rationale of GMP and the key role played by workers in the production and packaging of pure, safe, and quality products. --This text refers to an alternate Paperback edition.

Product Details

Paperback Publisher: Interpharm Pr; Intl edition (June 1992) ISBN-10: 9994014072 ISBN-13: 978-9994014071 Product Dimensions: 8.8 x 5.8 x 0.5 inches Shipping Weight: 1.6 ounces

Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance [Hardcover]

Syed Imtiaz Haider

(Author)

Editorial Reviews

Product DescriptionThe Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

Product Details

Hardcover: 208 pages Publisher: Informa Healthcare (December 27, 2001) Language: English ISBN-10: 1574443305 ISBN-13: 978-1574443301

Product Dimensions: 8.9 x 6.1 x 0.7 inches

Handbook of Pharmaceutical Granulation Technology (Drugs and the Pharmaceutical Sciences) [Hardcover]

Dilip M. Parikh (Editor)

B001JSB3Y4

Editorial Reviews

Review…comprehensive….

… very useful for pharmaceutical professionals.

-IASI Polytechnic Magazine (for previous edition) --This text refers to an alternate Hardcover edition.

Product DescriptionThis practical guide integrates the basic principles and current industrial practices of pharmaceutical granulation production;discussing state-of-the-art technologies and demonstrating cost-effective approaches to manufacturing solid-dosage forms with content uniformity and consistent physical properties while complying with regulatory requirements.

Product Details

Hardcover: 528 pages Publisher: Informa Healthcare (June 17, 1997) Language: English ISBN-10: 0824798821 ISBN-13: 978-0824798826 Product Dimensions: 9.1 x 6.1 x 1.3 inches

Shipping Weight: 1.7 pounds

Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences) [Hardcover]

Robert A. Nash (Editor), Alfred H. Wachter (Editor)

Editorial Reviews

Product DescriptionStevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate validation protocols and conduct process validation assignments, monitor and test specific manufacturing processes for compliance with design limits, and more.

Product Details

Hardcover: 776 pages Publisher: Informa Healthcare; 3 edition (March 27, 2003) Language: English ISBN-10: 0824708385 ISBN-13: 978-0824708382 Product Dimensions: 9.4 x 6.4 x 1.8 inches

Quality Control of Herbal Drugs [Hardcover]

Pulok K Mukherjee (Author)

Editorial Reviews

Product DescriptionAn exhaustive and comprehensive book available on the subject. It includes information on:

Safety and Toxicity in Herbal Drugs Ethnobotany in Drug Evaluation Macro-Morphographical Studies Development of Standardization Parameters Phytoconstituents and Their Analysis Extraction of Herbal Drugs TLC - Detailed Procedures and Guidelines HPTLC - Densitometry Pharmacological Screening of Herbal Drugs Good Agricultural and Harvesting Practices Quality Assurance and Stability Testing of Herbal Drugs Analytical Profiles of Selected Medicinal Plants

Plus Annexed Information

Additional References Internet Resources for further information International Associations/Organizations

You Need This Book If You Are :

Grower of medicinal herbs Wholesaler/Distributor Manufacturer of Herb Extracts Manufacturer of Herbal Formulations Researcher Academician Regulatory Affairs Specialist

About the AuthorDr. Pulok K Mukherjee obtained his Ph.D in herbal medicine and is a renowned personalty in the firel of herbal medicine. He has to his credit over 100 research papers in various international journals and one patent. He is presently Director, School of Natural Product Studies, Jadavpur University, Kolkata, India

Product Details

Hardcover: 816 pages Publisher: Business Horizons (May 2002) ISBN-10: 8190078844 ISBN-13: 978-8190078849 Product Dimensions: 9.7 x 7.4 x 1.7 inches

The Pharmaceutical Codex: Principles and Practice of Pharmaceutics (British Pharmaceutical Codex) [Hardcover]

Walter Lund (Editor)

Editorial Reviews

Product DescriptionThis edition of the codex has been revised and incorporates updated material as well as new subject areas. The codex provides a reference source on all aspects of pharmaceutical science and technology that are relevant to the development and provision of medicines.

Product Details

Hardcover: 1117 pages Publisher: Pharmaceutical Press; 12 edition (January 1994) Language: English ISBN-10: 0853692904 ISBN-13: 978-0853692904 Product Dimensions: 12.7 x 8.1 x 2.6 inches Shipping Weight: 4.8 pounds

Pharmaceutical Dosage Forms [Hardcover]

Herbert Lieberman (Editor), Martin Rieger (Editor), Gilbert S. Banker

(Editor)

Editorial Reviews

Review"…highly recommended." -- Pharmaceutical Development and Technology

"…highly valuable... "…manage[s] to nicely combine a historical account with the mandatory interpretation of governmental regulations. -- Pharmaceutical Development and Technology

Product DescriptionStressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this Second Edition of a well-received reference test highlights typical formulations, the avoidance of formulation pitfalls, and compliance with established regulatory principles.

Product Details

Hardcover: 552 pages Publisher: Informa Healthcare; 2 edition (May 16, 1996) Language: English ISBN-10: 0824793870 ISBN-13: 978-0824793876 Product Dimensions: 10.1 x 7.1 x 1.2 inches

B001KI623U

British Herbal Pharmacopoeia [Hardcover]

British Herbal Medicine Association (Author)

 Product Details

Hardcover: 212 pages Publisher: British Herbal Medicine Association (December 31, 1996) ISBN-10: 0903032104 ISBN-13: 978-0903032100 Product Dimensions: 9.7 x 7 x 0.8 inches Shipping Weight: 1.6 pounds

Pharmaceutical Dosage Forms: Tablets, Third Edition (Three-Volume Set) [Hardcover]

Larry L. Augsburger (Editor), Stephen W. Hoag (Editor)

Product DescriptionThe ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, and with over 700 illustrations it guides pharmaceutical scientists and engineers through difficult and technical procedures in a simple easy-to-follow format.

New to the third edition:

Product Details

Hardcover: 1616 pages Publisher: Informa Healthcare; 1 edition (June 3, 2008) Language: English ISBN-10: 1420063456 ISBN-13: 978-1420063455 Product Dimensions: 10.9 x 8 x 4.5 inches Shipping Weight: 7.4 pounds

Pharmaceutical Dosage Forms Tablets - 2nd Edition [Hardcover]

HALibrman (Author)

Product Details

Hardcover Publisher: Informa Hralthcarr,1990 (1990) ASIN: B003ZOPT2W

Pharmaceutical Dosage Forms: Parenteral Medications, Volume I (Parenteral Medications, 1) [Hardcover]

Kenneth E. Avis (Editor),

Editorial Reviews

ReviewThis book forms part of a 3-volume set which is a standard reference work for the formulation and manufacture of parenteral dosage forms. . . . . .coverage. . .is very comprehensive. . . . . .The entire series is probably the best source for information of the disparate multidisciplinary area we call pharmaceutics, and is essential reading for all in this area. ---Journal of Pharmacy and Pharmacology . . .Every chapter has been revised and updated to keep pace with advances in science and technology. The editors did a good job of systematically organizing the contents of the text into three volumes. . .The first volume deals with performultion, formulation, and product development. . . .well illustrated with photographs, diagrams, and flow charts. . .The contributing authors. . .have impressive credentials and their views and experiences enhance the value of the book. . .strongly recommend[ed]. . .for both students and professionals, both in academics and in industry. ---BioPharm

Product DescriptionUniversity of Tennessee, Memphis. Revised and expanded edition of an in-depth text on parenteral medications, for graduate and undergraduate students, and industrial or hospital pharmacists. To be completed in three volumes. Content for all volumes given in Volume 1. DNLM: Infusions.

Product Details

Hardcover: 580 pages Publisher: Marcel Dekker; 2nd, Revised and Expanded edition (January 15, 1992) Language: English ISBN-10: 0824785762 ISBN-13: 978-0824785765

Product Dimensions: 10.1 x 6.9 x 1.3 inches

The Theory and Practice of Industrial Pharmacy [Hardcover]

Leon Lachman

Product Details

Hardcover: 902 pages Publisher: Lea & Febiger; 3 Sub edition (August 1986) Language: English ISBN-10: 0812109775 ISBN-13: 978-0812109771

European Customs Inventory of Chemical Substances: A Guide to the

Classification of Chemicals in the Combined Nomenclature: Vol 1 [Import] [Paperback]

European Communities (Author)

Product Details

Paperback: 1213 pages Publisher: European Communities / Union (EUR-OP/OOPEC/OPOCE); 1997 Ed edition (January 1998) ISBN-10: 9282806375 ISBN-13: 978-9282806371 Shipping Weight: 1.1 pounds

SOP Guidelines [Hardcover]

D. H. Shah (Author)

Editorial Reviews

Product DescriptionIntroducing the Second Edition of our bestselling book, the new edition is now a comprehensive and cutting-edge guide to preparation and management of Standard Operating Procedures. It covers the fields of Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping. Contains actual full text SOPs that can be inorporated directly in your systems and modified as required. It includes for the first time, detailed and easy to understand methods of developing SOPs that are required by the manufacturer and regulatory agencies. Electronic SOP management systems and their desired structures are covered. Also included in the new edition are various systems of Electronic Batch Records and pharmaceutical ERP systems and their management. CONTENTS Introduction Preface to the1st Edition DESIGNING EFFECTIVE SOPs Introduction and Purpose of SOPs Benefits of SOPs Types of SOPs Contents of a Typical SOP Level of Detail Writing Style SOP Development Create/Edit Review Approve Publish Distribute Archive SOP Format Title Page Table of Contents Text Transition to Electronic SOPs Too Many Documents Over-complex Documents Inappropriate Format Management Systems Advantages of Electronic SOPs System Requirements Structure of eSOP System Audit Critical Activities Authenticate Users Keep Track of Who Has Seen What Validation Support Future of eSOP ELECTRONIC MANUFACTURING eMANUFACTURING Understanding the e in the eManufacturing Electronic Records Requirements for Electronic Records Risk Based Approach to Future Purpose of eManufacturing Introduction to Electronic Batch Records (EBR) Benefits of Electronic Batch Records (EBR) Plant Efficiencies Impact of QC Lab on Batch Cycle Time Management of Manufacturing Data User Requirement Specification (URS) Vendor Selection Qualification and Validation of Software Evolution from Paper to EBR Features of cGMP Compliant EBR System Process Historian for Management of Manufacturing Data Enterprise Resource Plan

About the AuthorD. H. Shah graduated in pharmacy in 1962 and in the last 40 years has been actively associated with manufacture of all categories of drug formulations. He is presently Technical Director with a few reputed pharmaceutical companies and is involved in quality assurance and GMP compliance activities. --This text refers to an out of print or unavailable edition of this title.

Product Details

Hardcover: 464 pages Publisher: Business Horizons; 2nd edition (November 15, 2006) Language: English ISBN-10: 8190078887 ISBN-13: 978-8190078887 Product Dimensions: 9.6 x 7.4 x 1.3 inches

Pharmaceutical Facility Management [Hardcover]

J P S Kohli (Author)

Editorial Reviews

Product DescriptionBusiness entities have come to realize that maintaining a well-managed and highly efficient facility is critical to success. New technologies, security issues and health concerns also have had a major impact on the importance of, and need for, facility professionals in organizations. Plant managers must therefore be equipped with a tremendous amount of knowledge and the ability to cope with and solve a multitude of complex problems and challenges. The current climate of increased inspections and scrutiny from the regulatory authorities on manufacturing, combined with the uncertainty of the equity markets, has elevated GMP compliance to a long-term business strategy. This unique book covers the often overlooked field of pharmaceutical facility management. In a running pharmaceutical plant, the plant manager often has to manage a wide range of activities including production, machine maintenance, building maintenance, training of personnel, validation programs, environmental monitoring and last but not the least – managing regulatory inspections. This wide spectrum of activities entails the involvement of people from production, quality control, engineering, quality assurance, housekeeping etc. thus demanding a lot of time and efforts from the plant manager to effectively synchronize all these activities. This book will help in designing and implementing all these required activities and help in streamlining the total functioning of a pharmaceutical facility. This is a must-have book that all plant mangers and others involved with a pharmaceutical manufacturing facility should have on their tables for ready reference.

About the AuthorJ. P. S. Kohli is a pharmacy graduate from University of Delhi followed by Diploma in Management of Technology Transfer, Patents and Information Systems. He has wide ranging experience in the pharmaceutical industry, having worked in a pharmaceutical engineering company followed by working in a pharmaceutical manufacturing facility as Manager-Projects and Exports. He later set up his own pharmaceutical engineering company providing technical audit services and engineering consultancy to pharmaceutical companies for all dosage forms like Tablets, Capsules, Dry Syrups, Liquid Orals, Ointments and Injectables.

Product Details

Hardcover: 328 pages Publisher: Business Horizons (May 2005) ISBN-10: 8190078860 ISBN-13: 978-8190078863 Product Dimensions: 9.3 x 7.2 x 0.9 inches

Principles & Practice Contamination

Control & Cleanrooms [Hardcover]

Product Details

Hardcover Publisher: Pharma Book Syndicate (January 1, 2003) ISBN-10: 8188449040 ISBN-13: 978-8188449040

QA Manual [Hardcover]

D. H. Shah (Author)

Editorial Reviews

Product DescriptionThis is a comprehensive and detailed guide to management of Quality Assurance in pharmaceutical production facilities.

It includes

Facility Design Equipment Production Controls Bulk Pharmaceutical Chemicals Laboratory Controls Personnel Validation Documentation Audits

A manufacturer must, in designing, making and marketing a medicine, satisfy the regulatory authorities and himself that his products are of adequate quality, safety and efficacy. Application of the principles of quality assurance and of good manufacturing surveillance, all contribute to the assurance of quality. The purpose of this book therefore is to provide an instant knowledge-base of such systems and procedures which will help a pharmaceutical manufacturer to comply with most countries legislation's with regard to quality assurance and cGMP requirements.

About the AuthorD. H. Shah graduated in pharmacy in 1962 and in the last 40 years has been actively associated with manufacture of all categories of drug formulations. He is presently Technical Director with a few reputed pharmaceutical companies and is involved in quality assurance and GMP compliance activities.

Product Details

Hardcover: 312 pages Publisher: Business Horizons (May 2002) ISBN-10: 8190078828 ISBN-13: 978-8190078825 Product Dimensions: 9.4 x 7.1 x 0.8 inches

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007: aka the Orange Guide [Paperback]

MHRA (Editor)

Editorial Reviews

Product DescriptionFamiliarly known as the "Orange Guide," this title combines the major pharmaceutical Regulations, Directives and guidance, which wholesalers and the pharmaceutical industry use as their main source when manufacturing and distributing medicinal products in the EU.

Product Details

Paperback: 430 pages Publisher: Pharmaceutical Press; 1 edition (February 28, 2007) Language: English ISBN-10: 0853697191 ISBN-13: 978-0853697190 Product Dimensions: 9.4 x 6.8 x 0.9 inches

Good Manufacturing Practices and Inspection (Quality Assurance of Pharmaceuticals) [Paperback]

World Health Organization (Author)

Editorial Reviews

Product DescriptionQuality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control, and in the pharmaceutical industry.

About the AuthorUNAIDS

Product Details

Paperback: 413 pages Publisher: World Health Organization; 2 Updated edition (June 6, 2007) Language: English ISBN-10: 9241547081 ISBN-13: 978-9241547086 Product Dimensions: 9.4 x 6.2 x 1 inches

Drug Formulations ManualD.P.S. Kohli and D.H. Shah, Eastern Publishers, 2005, Third Edition, 534 p, figs, tables

From the preface: "The third edition enlists 420 drug formulations and manufacturing processes. Some of the 39 new formulations now included are: Acarbose tablets, Glimepiride and pioglitazone hydrochloride tablets, Metformin and glipizide tablets, Atorvastatin tablets, Clopidogrel tablets, Nabumetrone tablets, Fexofenadine tablets, Riserpridone tablets, Gatifloxacin tablets, Gabapentin capsules, Nicerbium tablets, Rampril capsules and 27 more formulations."

Quality Assurance in Spices And Spice Products ; Modern of Analysis Product Details

Unknown Binding Publisher: Allied Publishers Pvt. Ltd. (1999) ISBN-10: 817023896X ISBN-13: 978-8170238966

Clarke's Analysis of Drugs and Poisons, Third Edition [Hardcover]

Anthony C. Moffat (Editor)

Editorial Reviews

Product DescriptionUniv. of London, UK. Reference guide provides analytical data for drugs and poisons. First volume details analytical toxicology techniques and the second volume deals with the applications of toxicology techniques in a wide variety of settings. Features more than 1,730 monographs. Previous edition: c1986, was titled Clarke's Isolation and Identification of Drugs.

Product Details

Hardcover: 1248 pages Publisher: Pharmaceutical Press; 3 edition (February 29, 2004) Language: English ISBN-10: 0853694737 ISBN-13: 978-0853694731 Product Dimensions: 11.6 x 9.3 x 4.1 inches

Facility Validation: Theory, Practice, and Tools

Graham C. Wrigley

(Author)

B001KIDDBO

Editorial Reviews

Product DescriptionFocusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provide definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a comprehensive glossary of validation terminology, and best practices for evaluating validation programs.

Product Details

Hardcover: 160 pages Publisher: Informa Healthcare; 1 edition (March 29, 2004) Language: English ISBN-10: 0849323401 ISBN-13: 978-0849323409 Product Dimensions: 9.3 x 6.2 x 0.6 inches

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices [Hardcover]

Kim Huynh-Ba (Editor)

Editorial Reviews

Product Description

A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT

Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners.

Topics covered include:

Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.

Post-approval considerations and regulatory filing strategies to support a global supply chain. Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also

discusses physical stability, non-chromatographic methodologies, and spectroscopic applications. Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT). USP-NF testing in support of stability. Current industry best practices on stability operation, validation, and calibration of stability chambers including

considerations for photo-stability testing. Discussion of matrixing and bracketing to support reduced stability testing. Overview of stability programs for biologics and drug-in-devices pharmaceutical products.

This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

About the Author

Kim Huynh-Ba is Technical Director of Pharmalytik. She has over 20 years of experiences in various analytical areas of pharmaceutical development, especially in Stability Sciences. She has involved with several projects harmonizing or optimizing analytical best practices in several companies, including those are under Consent Decree. Ms. Huynh-Ba has authored numerous technical publications and book chapters. She is a frequent invited speaker at national and international conferences. She has conducted several training courses on stability compliance and quality issues for American Chemical Society, American Association of Pharmaceutical Scientists, Pharmaceutical Training Institute, Eastern Analytical Symposium since 2001. She is the founder of AAPS Stability Focus Group and actively involved with Pharmaceutical Stability Discussion Group. She is an active member of ACS, AAPS, PSDG, ASQ, POMA and serves in the Governing Board of Eastern Analytical Symposium (EAS).

In my professional career as a pharmaceutical scientist, I have been involved with several aspects of the drug development process from pre-IND to commercial and, somehow, I usually found myself coming back to a stability related issue. Stability area seems to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues

was the same. Each situation posed challenges that usually required an exercise of judgment, an understanding of regulations, knowledge of science, a grasp of compliance, and an appreciation of common practices.

Since early 2000, I have also been involved with several training opportunities and I struggled to find good, concise, practical resources, one of which I can just hand to a new scientist who wishes to gain more understanding of stability sciences. In addition, I encountered the same questions posted over and over on different stability best practices discussion forums.

As a book lover, I also have a good collection of technical books. Unfortunately, most of the stability related books are outdated. In addition, many of these materials are theoretical and do not contain much practical information. I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changing rapidly while regulatory agencies are working closely with the pharmaceutical industry to accommodate these changes; however, the fundamental information continues to remain quite the same as current Good Manufacturing Practices (cGMP) continues to be the standard industry practice. Therefore, I hope to assemble a practical handbook to fill this void.

Product Details

Hardcover: 389 pages Publisher: Springer; 1 edition (November 21, 2008) Language: English ISBN-10: 0387856269 ISBN-13: 978-0387856261 Product Dimensions: 9.3 x 6.2 x 1.1 inches

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical [Hardcover]

Syed Imtiaz Haider

(Author)

B001JSB3Y4

Editorial Reviews

Product DescriptionOne of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required. This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States. The CD-ROM contains 74 template validation standard operating procedures that can be tailored to meet the regulatory compliance requirements of any pharmaceutical, diagnostic, medical device, medical equipment, and biotech product. You can edit, print, and customize these procedures to fit your needs. The book and CD work together to minimize the number of documents used and to ensure their accuracy. All critical elements and requirements of validation are covered, so you can easily implement them and avoid the stress that usually accompanies an FDA audit.Features"Provides all the information that managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines"Includes step-by-step directions for translating GMP requirements into action, based on your company's Master Validation Plan and execution protocols "Describes how to establish test functions and prevent defects in order to produce products that are fit for use"Serves as an ideal companion to Haider's Pharmaceutical Master Validation Plan

About the AuthorHaider; Syed Imtiaz Gulf Pharmaceuticals Industries, United Arab Emirates,

Product Details

Hardcover: 496 pages Publisher: Informa Healthcare; 1 edition (December 27, 2001) Language: English ISBN-10: 1574443313 ISBN-13: 978-1574443318 Product Dimensions: 9.5 x 6.3 x 1.3 inches

British Pharmacopoeia 1980: 2v [Hardcover]

Dept.of Health & Social Security (Author)

Product Details

Hardcover: 1226 pages Publisher: Stationery Office Books; 2nd edition (June 1, 1980) ISBN-10: 0113206887 ISBN-13: 978-0113206889

The Pharmacopeia of the United States of America (The United States pharmacopeia) (1820)

Author: United States Pharmacopoeial ConventionVolume: 1905 8 ed.Subject: PharmacopoeiasPublisher: Easton, Pa. [etc.]Language: EnglishCall number: AAX-3311Digitizing sponsor: University of TorontoBook contributor: Gerstein - University of TorontoCollection: toronto

Description

Title varies slightly

1820-1975 issued by authority of the United States Pharmacopoeial Convention (1820-90 under various earlier names of the Convention)

Some revisions have supplements

Supplements issued 1975-79 also cover the National formulary (RS141.2N3)

Continued by the United states pharmacopeia

Analytical Method Validation and Instrument Performance Verification [Hardcover]

Tze-Fun Chan (Editor),

Editorial Reviews

Review“It is a treasure of helpful hints and techniques which can aid even experienced analysts through some of the ICH procedures.” (Metrohm Information, 4th July 2005)

"While most useful for pharmaceutical laboratories, it may also be useful in certain university and government laboratories." (E-STREAMS, February 2005)

"…a treasure of helpful hints and techniques that can aid even experienced analysts through some of the ICH procedures." (Inside Laboratory Management, July/August 2004)

"Given the need for generating reliable analytical data, this book provides practical guidance for validating common and not-so-common analytical methods and for verifying the performance of instruments…" (Journal of the American Chemical Society, June 9, 2004)

“…a very useful reference text…warmly recommended” (Organic Process Research & Development Journal)

Product DescriptionValidation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

See all Editorial Reviews

Product Details

Hardcover: 320 pages Publisher: Wiley-Interscience; 1 edition (January 28, 2004) Language: English ISBN-10: 0471259535 ISBN-13: 978-0471259534 Product Dimensions: 9.4 x 6.4 x 0.8 inches

Pharmaceutical Analysis [Hardcover]

T. Higuchi (Editor)

Product Details

Hardcover: 854 pages Publisher: John Wiley & Sons Inc (December 1961) Language: English ISBN-10: 0470395346 ISBN-13: 978-0470395349

Validation and Qualification in Analytical Laboratories [Hardcover]

Ludwig Huber

(Author)

Editorial Reviews

Reviewa great single reference containing all you ever wanted to know about validating and verifying assay or equipment performance. Doody’s Review - Valerie L. Ng, PhD, MD

B001JSB7IQ

Product DescriptionThis Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Product Details

Hardcover: 288 pages Publisher: Informa Healthcare; 2 edition (July 23, 2007) Language: English ISBN-10: 084938267X ISBN-13: 978-0849382673 Product Dimensions: 9 x 6.1 x 0.8 inches

British Pharmaceutical Codex 1973 [Hardcover]

Pharmaceutical Society of Great Britain (Author)

Product Details

Hardcover: 1024 pages Publisher: The Pharmaceutical Press (June 1973) Language: English ISBN-10: 0853690847 ISBN-13: 978-0853690849

Microbiological Contamination Control in Pharmaceutical Clean Rooms [Hardcover]

Nigel Halls (Editor)

Editorial Reviews

Review…Throughout the book one finds concise, practical and helpful chapters and sections. Everything within the book avoids unnecessary descriptions, but comes to the point underlined by years of experience….

…an excellent practical reference….An enjoyment to read and learn.-European Journal of Parenteral and Pharmaceutial Sciences

Product DescriptionThis book neatly clarifies some of the perceived problems surrounding contamination control in pharmaceutical industry clean rooms. It helps manufacturers satisfy both domestic and international regulations and prevents their companies from suffering the consequences of non-compliance. It includes up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control. This book is a must for the microbiologist working in pharmaceutical manufacturing. INV STAT: Not yet published

Product Details

Hardcover: 200 pages Publisher: CRC Press; 1 edition (June 26, 2004) Language: English ISBN-10: 0849323002 ISBN-13: 978-0849323003 Product Dimensions: 9.5 x 6.4 x 0.7 inches

Troubleshooting HPLC Systems: A Bench Manual Paul C. Sadek (Author)

Product DescriptionA complete, up-to-date guide to the use, maintenance, and troubleshooting of HPLC systems

The last twenty-five years have seen a dramatic rise in the use of High Performance Liquid Chromatography (HPLC) in laboratories worldwide. Troubleshooting HPLC Systems provides analysts as well as laboratory technicians and managers with a readily accessible and immensely useful guide to the new generation of HPLC equipment and techniques. With an emphasis on effective troubleshooting of HPLC systems, this lab companion covers system configuration and functions, problem-solving procedures, maintenance, and HPLC basics. It then walks chromatographers investigating the source of a malfunction through each system component-from solvents and reservoirs to sample preparation to columns and detectors. Special features of Troubleshooting HPLC Systems include:* A detailed review of HPLC instrumentation and accessories* The role of operating parameters as indicators of system performance* Step-by-step troubleshooting protocols for each system component* How to set up a preventive maintenance program for HPLC systems* An overview of the categories of HPLC separations* A compilation of HPLC terms and definitions* Tables and charts detailing solvents' properties

See all Editorial Reviews

Product Details

Spiral-bound: 306 pages Publisher: Wiley-Interscience (October 5, 1999) Language: English ISBN-10: 0471178349 ISBN-13: 978-0471178347 Product Dimensions: 9.2 x 6.6 x 1.1 inches

Good Manufacturing Practices for Pharmaceuticals, Sixth Edition (Drugs and the Pharmaceutical Sciences) [Hardcover]

Graham Bunn (Author)

Product DescriptionWith global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

Product Details

Hardcover: 424 pages Publisher: Informa Healthcare; 6 edition (December 26, 2006) Language: English ISBN-10: 0849339723 ISBN-13: 978-0849339721 Product Dimensions: 10.1 x 7 x 1.1 inches

Handbook of Pharmaceutical Analysis by HPLC, Volume 6 (Separation Science and Technology) [Hardcover]

Satinder Ahuja (Editor)

Product DescriptionHigh pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening,

* A complete reference guide to HPLC* Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development* Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

See all Editorial Reviews

Product Details

Hardcover: 600 pages Publisher: Academic Press; 1 edition (April 12, 2005) Language: English ISBN-10: 0120885476 ISBN-13: 978-0120885473

United States Pharmacopoeia 33 - National Formulary 28Author:

Unites States Pharmacopoeia Convention

Print Version

The United States Pharmacopoeia 33 - National Formulary 28 (USP 33-NF 28) is a three-volume combination of two official compendia, the United States Pharmacopoeia (USP) and the National Formulary (NF). USP-NF is an annual publication, comprising of one main publication and two supplements each year.

In January 2010 USP recalled USP 33-NF 28 and subsequently reissued a revised publication in April 2010. Purchasers of the original USP 33-NF 28 will have been sent the revised edition called USP 33-NF 28 Reissue. New customers will simply receive the official, fully revised reissue version.

Customers benefit from:

Individually bound print copy of USP 33-NF 28 Reissue New and Revised Official Text Since the Second Supplement to USP 32-NF 27

Individually bound print copy of First Supplement to the USP 33-NF 28 Reissue Individually bound PRINT copy of Second Supplement to the USP 33-NF 28 Reissue (June 2010) Designed to fit in

compact storage facilitity which comes with the order.

CD-Rom features:

USP 32-NF 27 and its supplements USP 33-NF 28 Reissue New and Revised Official Text Since the Second Supplement to USP 32-NF 27 First Supplement to the USP 33-NF 28 Reissue

The USP 33-NF 28 becomes official on 01 May 2010. The First Supplement is available from February 2010 and becomes official on 01 August 2010. The Second Supplement is available from June 2010 and becomes official on 01 December 2010.

The USP-NF provides access to official standards, enforceable by the U.S. Food and Drug Administration for drugs and related products manufactured and marketed in the United States. In addition, the USP serves as a clear step-by-step guide for the specifications - tests, procedures, and acceptance criteria - required for pharmaceutical manufacturing and quality control.

USP 33-NF 28 includes more than 4200 monographs for drugs, excipients, biologics and dietary supplements. The monograph design is in a new easy-to-read format with concise language. Format developments include:

Tests and procedures clearly designated in a logical flow Reorganised content; sub-headings reordered and renamed to meet ICH specifications Calculations have been expanded to provide more details; added impurity tables and heavy metal units updated to ppm Preparation of solutions are abbreviated and a new streamlined format used.

The USP-NF is an essential publication for anyone working in pharmaceuticals, biotechnology, dietary supplements, medical devices and gases and veterinary drugs and is also is an important reference for pharmacies, libraries, universities, and schools of medicine and pharmacy.

The print edition of USP-NF is printed on a thick, durable paper stock suitable for laboratory use. The English edition is shipped in a convenient slipcase for easy access and storage.

The USP-NF is a subscription product, with a fixed subscription period of November 2009 to October 2010.

Key features:

Official, fully revised reissue Compact storage case Print and user-friendly CD-ROM combination package More than 4,400 monographs Over 200 general chapters covering general tests and assays A new, easy-to-read format and monograph layout

Helpful guides and charts that make it easy to find focus-specific information Ensures compliance with official standards Establishes in-house standard operating procedures and specifications Facilitates new product development and approval.

Extent 3 Volumes Sub. No. 7701014

Size tbc Price £752.00

Binding Hardback Frequency Annual

British Pharmacopoeia 2010 [Hardcover]

Stationery Office (U. k.) (Author)

Product DescriptionProduced by the British Pharmacopoeia Commission Secretariat, The British Pharmacopoeia (BP) 2010 is the leading collection of standards for UK medicinal products and pharmaceutical substances. Now used in almost 100 countries, the BP remains an essential reference for all individuals and organisations working within pharmaceutical research and development, manufacture, and testing across the globe. Key Features: Legally effective in the UK from 1 January 2010, 40 new monographs for formulated preparations, New and revised monographs for Herbal and Complementary Medicines within their own section in Volume III, Additional standards for widely used unlicensed formulations, and European Pharmacopoeia 6th edition material up to and including Supplement 6.5. European Pharmacopoeia monographs are clearly distinguished and cross-referenced while a full index ensures easy access to the current legally binding UK standards.

Product Details

Hardcover: 5300 pages Publisher: Stationery Office Books (TSO); 1 edition (August 15, 2009) Language: English ISBN-10: 0113228287 ISBN-13: 978-0113228287

European Pharmacopoeia 6.0 [Hardcover]

Council of Europe (Corporate Author)

The 6th edition of the European Pharmacopoeia came into force on 1 January 2008 and consists of a two-volume main edition. It will be updated on a regular basis with one supplement following in October 2007, three in 2008 and 2009, and the remaining supplement in 2010 to create a collection of eight non-cumulative supplements.

Key features:

Over 1,800 specific and general monographs will be published. Contains all types of active substances used to prepare pharmaceutical products: various chemical substances, antibiotics,

biological substances, vaccines for human or veterinary use, Immunosera, Radiopharmaceutical preparations, herbal drugs and homoepahtic preparations.

Also contains dosage forms, general monographs, materials, containers and sutures. Around 268 general methods with figures or chromatograms. Over 2210 reagents will be described.

This publication is available in Print, CD-ROM and Pack format. Supplements 6.1, 6.2, and 6.3 are available to buy separately. Supplements 6.3, 6.4 and 6.5 are also available to buy as a pack, please see below.

Extent 4,392 pages ISBN 9789287160546

Size 215 x 302mm Price £259.00

Binding Hardback Published 23 Jul 2007

The International PharmacopoeiaFourth EditionAuthor:

World Health Organization (WHO)

'The International Pharmacopoeia - Fourth Edition' consolidates the texts of the five separate volumes of the third edition. Certain additions and amendments have been made to the notices in order to clarify the interpretation of the Pharmacopoeia and to facilitate application of the requirements by the user.

This fourth edition will include all the monographs in the third edition together with new monographs for didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, saquinovir mesilate. All the monograph texts are brought together in one section and the method texts in another. Each of these major sections are divided into appropriate sub-sections and the method texts are numbered for ease of cross-reference.

Method texts that have been updated include, for example, the text on high performance liquid chromatography [HPLC]. This has been revised to clarify certain technical terms and to add advice on adjustment of chromatographic conditions, as recommended by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004.

Extent 2 Volumes / 1499 pages ISBN 9789241563017

Size 160 x 240mm Price £200.00

Binding Hardback Published 28 Feb 2007

Martindale: The Complete Drug Reference, 36th Edition (2 Volume Set) [Hardcover]

Sean C. Sweetman (Editor)

Product DescriptionThis book provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to existing drug names and formulations, which can affect their interactions and safe usage. Health professionals require the correct answers and need to have confidence in the drugs information they use - but with medicines evolving at this rate, how can they be sure their knowledge is up to date? "Martindale" contains up to date information about more than 5,800 substances. Each and every entry is reviewed by our pharmaceutical editors to ensure health professionals have the most current data. Formulations change. Definitions change. Names change. But you can always trust "Martindale".

Product Details

Hardcover: 3694 pages Publisher: Pharmaceutical Press; 36 edition (March 16, 2009) Language: English ISBN-10: 0853698406 ISBN-13: 978-0853698401 Product Dimensions: 14.2 x 10 x 5.2 inches

Japanese Pharmacopeia (Pharmacopoeia of Japan) [Hardcover]

Yakuji Nippo Ltd (Corporate Author)

Product Details

Hardcover: 1788 pages Publisher: Maruzen Company, Ltd.; 15 edition (March 2006) Language: English ISBN-10: 4840809747 ISBN-13: 978-4840809740

The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals [Hardcover]

Maryadele J. O'Neil (Editor)

Product DescriptionThe Merck Index is a one-volume encyclopedia of chemicals, drugs and biologicals that contains more than 10,000 monographs. Each monograph in this authoritative reference source is a concise description of a single substance or a small group of closely related compounds.

Compounds included:

•       human and veterinary drugs

•       biotech drugs and monoclonal antibodies

•       substances used for medical imaging

•       biologicals and natural products

•       plants and traditional medicines

•       nutraceuticals and cosmeceuticals

•       agriculturals, pesticides and herbicides

•       Organic chemicals used in research

•       Food additives and supplements

•       dyes, colors and indicators

•       environmentally significant substances

Information provided:

•       chemical, common and generic names

•       Over 15,000 trademarks and associated companies

•       CAS Registry Numbers for over 12,000 compounds

•       Over 8,500 chemical structures

•       molecular formulae, weights and percentage composition

•       capsule statements identifying compound classes and scientific significance

•       scientific and patent literature references

•       physical and toxicity data

•       therapeutic and commercial uses

•       caution and hazard information

In addition, there are more than 700 new and completely revised monographs, thousands of new references, trademarks and uses added to existing monographs.  Now includes a companion CD-ROM which features 989 monographs no longer available in print, organic name reactions, supplemental tables and a new user interface for user-friendly searching.

Features of the CD:

Searchable by keywords, references, and numerical properties Search the complete contents of the 14th edition, plus nearly a thousand monographs archived from previous editions Comes with a free one-year subscription to the Merck Index Internet Edition Windows-compatible CD powered by CambridgeSoft's ChemFinder Extensively revised supplemental tables now including acronyms, vaccines, and physical constants More than 70 pages of hard to find information in one easy-to-use place

Product Details

Hardcover: 2564 pages Publisher: Merck; 14 edition (November 3, 2006) Language: English ISBN-10: 091191000X ISBN-13: 978-0911910001

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Health

Publisher: Informa HealthCare | 2003-12-18 | 969 Pages | ISBN: 0849318718 | PDF | 13.6 MB

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture.The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice [Hardcover]

Joachim Ermer

(Editor)

Product DescriptionAdopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of

B0034PTP3Q

pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness.

Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.

With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

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Product Details

Hardcover: 418 pages Publisher: Wiley-VCH; 1 edition (May 9, 2005) Language: English ISBN-10: 3527312552 ISBN-13: 978-3527312559 Product Dimensions: 9.6 x 7 x 1 inches

Development and Validation of Analytical Methods, Volume 3 (Progress in Pharmaceutical and Biomedical Analysis)C.M. Riley (Author

Product DescriptionThe need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations.

The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.

Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples.

Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.

This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

Product Details

Hardcover: 362 pages Publisher: Pergamon; 1 edition (June 12, 1996) Language: English ISBN-10: 0080427928 ISBN-13: 978-0080427928 Product Dimensions: 9 x 6.1 x 1 inches

Computer Applications in Pharmaceutical Research and Development (Wiley Series in Drug Discovery and Development) [Hardcover]

Sean Ekins

(Editor)

B003BFP2E0

Product DescriptionA unique, holistic approach covering all functions and phases of pharmaceutical research and development

While there are a number of texts dedicated to individual aspects of pharmaceutical research and development, this unique contributed work takes a holistic and integrative approach to the use of computers in all phases of drug discovery, development, and marketing. It explains how applications are used at various stages, including bioinformatics, data mining, predicting human response to drugs, and high-throughput screening. By providing a comprehensive view, the book offers readers a unique framework and systems perspective from which they can devise strategies to thoroughly exploit the use of computers in their organizations during all phases of the discovery and development process.

Chapters are organized into the following sections:* Computers in pharmaceutical research and development: a general overview* Understanding diseases: mining complex systems for knowledge* Scientific information handling and enhancing productivity* Computers in drug discovery* Computers in preclinical development* Computers in development decision making, economics, and market analysis* Computers in clinical development* Future applications and future development

Each chapter is written by one or more leading experts in the field and carefully edited to ensure a consistent structure and approach throughout the book. Figures are used extensively to illustrate complex concepts and multifaceted processes. References are provided in each chapter to enable readers to continue investigating a particular topic in depth. Finally, tables of software resources are provided in many of the chapters.

This is essential reading for IT professionals and scientists in the pharmaceutical industry as well as researchers involved in informatics and ADMET, drug discovery, and technology development. The book's cross-functional, all-phases approach provides a unique opportunity for a holistic analysis and assessment of computer applications in pharmaceutics.

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Product Details

Hardcover: 817 pages Publisher: Wiley-Interscience (June 30, 2006) Language: English ISBN-10: 0471737798 ISBN-13: 978-0471737797

SAS Programming in the Pharmaceutical Industry [Paperback]

Jack Shostak

(Author)

Product DescriptionAt last! A real-world reference guide for clinical trial SAS programming, packed with solutions that programmers can apply to their day-to-day problems. Discover key techniques and tools available within Base SAS (including the macro language and PROC SQL), SAS/GRAPH, and SAS/STAT that can be used to resolve many common issues in working with clinical trial data. Organized to reflect the statistical programmer's work flow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. Valuable plug-and-play programming examples are provided throughout. Whether you're a novice seeking an introduction to SAS programming for the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, you'll find a wealth of practical suggestions to help you sharpen your skills.

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Product Details

Paperback: 360 pages Publisher: SAS Publishing; 1 edition (September 2005) Language: English ISBN-10: 1590477936 ISBN-13: 978-1590477939

B001K8CN9W

Liquid Interfaces in Chemical, Biological, and Pharmaceutical Applications (Surfactant Science Series)

Alfred H. Wachter (Author)

Product DescriptionA reference describing interfacial phenomena in chemistry, biology, physics and medicine, of liquid interfaces. Includes more the 700 equations, 430 drawings and photographs, 2,800 references, and contributions from more than 60 international authors. Complete coverage of surface chemistry and its applications in a variety of fields.

Product Details

Hardcover: 888 pages Publisher: CRC Press; 1st edition (February 15, 2001) Language: English ISBN-10: 0824704576 ISBN-13: 978-0824704575

HPLC Methods for Recently Approved Pharmaceuticals [Hardcover]

George Lunn

(Author)

B001H6U7KY

Product DescriptionAn indispensable resource for busy researchers

Your time is valuable-too valuable to spend hunting through the technical literature in search of the right HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals, you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to original source publications. More of your time can then be spent in the lab, not the library.

Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for hundreds of newly approved drugs, as well as drugs for which assay methods were only recently developed. Combining detailed descriptions of procedures with specially annotated references, this practical handbook gives you:* HPLC methods for 390 commonly prescribed pharmaceutical compounds* Various procedures for each drug listed together-making it easy to mix and match for customized approaches* Methods for drugs in biological fluids and for bulk and formulated drugs* Chemical structures, molecular weights and formulas, and CAS Registry Numbers* Cross-references to The Merck Index* Retention times of other drugs that can be assayed using the same methods

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Product Details

Hardcover: 744 pages Publisher: Wiley-Interscience; 1 edition (April 18, 2005) Language: English ISBN-10: 0471669415 ISBN-13: 978-0471669418

Pharmaceutical Extrusion Technology (Drugs and the Pharmaceutical Sciences) [Hardcover]

Isaac Ghebre-Selassie

Editorial Reviews

Product DescriptionThe only book to bring together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. Provides in-depth descriptions and analyses of the key parameters of extruders and extrusion processes—highlighting the applicability of melt extrusion in pharmaceutical drug development and product manufacturing.

Product Details

Hardcover: 420 pages Publisher: Informa Healthcare; 1 edition (May 1, 2003) Language: English ISBN-10: 0824740505 ISBN-13: 978-0824740504

International Pharmaceutical Product Registration [Hardcover]

A.C. Cartwright (Editor),

Product DescriptionThis reference text for the pharmaceutical industry sets out the regulatory requirements of the authorities of the major world market. The editors identify major key technical and scientific areas in any application for marketing authorization.

Product Details

Hardcover: 968 pages Publisher: Informa Healthcare (April 1994) Language: English ISBN-10: 013474974X ISBN-13: 978-0134749747

Pharmaceutical Microbiology [Paperback]

W. B. Hugo

Product DescriptionFormerly Univ. of Nottingham, UK. Text for pharmacy undergraduate students on microbiology as it relates to pharmacy, such as mode of action of antibiotics or the manufacture and quality control of pharmaceutical agents. Previous edition: c1992. Halftone illustrations. Referenced. Softcover.

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Product Details

Paperback: 510 pages Publisher: Wiley-Blackwell; 6 edition (July 15, 1998) Language: English ISBN-10: 063204196X ISBN-13: 978-0632041961

Pharmaceutical Substances: Syntheses, Patents, ApplicationsAxel Kleemann

Product DescriptionPharmaceutical Substances is the newly revised and expanded edition of "Pharmazeutische Wirkstoffe" in English, covering over 2,100 pharmaceutical compounds of interest to the chemical and pharmaceutical industry. Available in print and CD-ROM, Pharmaceutical Substances is designed to be a complete reference guide to every pharmaceutical compound of significance. It is essential as a first point of reference not only for specialists in drug chemistry but also for anyone involved in the synthesis or use of pharmaceuticals. All compounds are organized alphabetically according to INN standard, for added ease of use the book features three additional indexes: Intermediates Enzymes, Microorganisms, Plants and Animal Tissues Substance Classes The CD-ROM will allow field, full text and index searching. It includes a browse function to allow you to peruse the data alphabetically by INN. It will be updated annually with 50 to 100 new compounds added each year.

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Product Details

Hardcover: 2488 pages Publisher: Thieme Medical Publishers; 4th edition (January 2001) Language: English ISBN-10: 3135584046 ISBN-13: 978-3135584041

Transport Processes in Pharmaceutical Systems (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs)

L. Amidon

Product DescriptionUniv. of Michigan, Ann Arbor. Explains pharmaceutical transport phenomena, demonstrating applications ranging from drug or nutrient uptake into vesicle or cell suspensions, to heat and mass transport in freeze-drying and hygroscopicity. For researchers.

Product Details

Hardcover: 727 pages Publisher: Informa Healthcare; 1st edition (January 15, 2000) Language: English ISBN-10: 0824766105 ISBN-13: 978-0824766108

Industrial Pharmaceutical Biotechnology [Hardcover]

Heinrich Klefenz

Product DescriptionThis volume focuses on pharmaceutical biotechnology as a key area of life sciences. The complete range of concepts, processes and technologies of biotechnology is applied in modern industrial pharmaceutical research, development and production. The results of genome sequencing and studies of biological-genetic function are combined with chemical, micro-electronic and microsystem technology to produce medical devices and diagnostic biochips. A multitude of biologically active molecules is expanded by additional novel structures created with newly arranged gene clusters and bio-catalytic chemical processes.New organisational structures in the co-operation of institutes, companies and networks enable faster knowledge and product development and immediate application of the results of research and process development.This book is the ideal source of information for scientists and engineers in research and development, for decision-makers in biotech, pharma and chemical corporations, as well as for research institutes, but also for founders of biotech companies and people working for venture capital corporations.

Product Details

Hardcover: 393 pages Publisher: Wiley-VCH; 1 edition (May 7, 2002) Language: English ISBN-10: 3527299955 ISBN-13: 978-3527299959

Affinity Capillary Electrophoresis in Pharmaceutics and Biopharmaceutics (Drugs and the Pharmaceutical Sciences) [Hardcover]

Reinhard H.H. Neubert (Editor)

Product DescriptionMartin-Luther-University, Halle-Wittenberg, Germany. Text presents recent breakthroughs and techniques in affinity capillary electrophoresis to measure and determine the physicochemical and thermodynamic parameters of drug compounds. Offers strategies to explore and characterize interactions between drugs.

Product Details

Hardcover: 384 pages Publisher: Informa Healthcare; 1 edition (January 14, 2003) Language: English ISBN-10: 0824709519 ISBN-13: 978-0824709518

Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences) [Hardcover]

Steven W. Baertschi (Editor)

Product DescriptionThe first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.

Product Details

Hardcover: 482 pages Publisher: Informa Healthcare; 1 edition (June 24, 2005) Language: English ISBN-10: 0824740211 ISBN-13: 978-0824740214

Bioavailability and Bioequivalance in Pharmaceutical Technology [Paperback]

Pal (Author)

Book: Bioavailability And Bioequivalence In Pharmaceutical TechnologyAuthor: PalISBN: 8123911580

Publishing Date: 2006-12-01Publisher: Cbs Publishers And DistributorsEdition: 1stNumber of Pages: 159Language: English

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (Pharmaceutical Science Series) [Hardcover]

Rosamund M. Baird (Editor)

Product DescriptionThis book will be a practical guide to techniques used in microbial quality assurance in the pharmaceutical industry. It aims to fill the gap in the literature between food and medical microbiology techniques books.

Product Details

Hardcover: 280 pages Publisher: CRC Press; 1 edition (August 17, 2000) Language: English ISBN-10: 074840614X ISBN-13: 978-0748406142

Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set) [Hardcover]

Sarfaraz K. Niazi

Product Description

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.

Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

cGMP compliance pre-approval inspections stability and bioequivalence testing packaging commodity development common difficulties in formulating drugs changes to aNDAs

Product Details

Hardcover: 2094 pages Publisher: Informa Healthcare; 2 edition (September 21, 2009) Language: English ISBN-10: 1420081063 ISBN-13: 978-1420081060 Product Dimensions: 16.4 x 12.3 x 8.5 inches

Validation and Qualification in Analytical Laboratories

Ludwig Huber

(Author)

B001JSB7IQ

Product DescriptionThis Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Product Details

Hardcover: 288 pages Publisher: Informa Healthcare; 2 edition (July 23, 2007) Language: English ISBN-10: 084938267X ISBN-13: 978-0849382673 Product Dimensions: 9 x 6.1 x 0.8 inches

Hvac Systems Duct Design [Paperback]

Smacna

Product Details

Paperback Publisher: Sheet Metal & Air Conditioning; 3rd edition (June 1990) ISBN-10: 9991623825 ISBN-13: 978-9991623825 Product Dimensions: 11.2 x 8.8 x 1 inches

Pharmaceutical Suspensions: From Formulation Development to Manufacturing

Pharmaceutical Suspensions: From Formulation Development to Manufacturing Publisher: Springer | Pages: 323 | 2009-10-16 | ISBN 1441910867 | 5 MB

The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable dispersions over the shelf life of the drug product continues to be a challenge on many fronts.

A good understanding of fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of suspension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with regulatory guidelines. Pharmaceutical Suspensions, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical active dispersed in a suitable vehicle.

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form [Hardcover]

Mark Gibson (Author)

Product DescriptionWritten by a panel of experts, this book covers every stage of drug development, from candidate drug selection to commercial formulation. It provides practical reference and pragmatic guide on what studies need to be undertaken, for what reasons, and at what key stages of the drug development process. Going beyond coverage of preformulation, the book discusses biopharmaceuticals, drug delivery, formulation, and process development aspects of product development. The contributing authors share their experience and expertise in significant chapters divided into three useful sections: Aiding Candidate Drug Selection, Early Drug Development, and From Product Design to Commercial Dosage Form. Features

Product Details

Hardcover: 596 pages Publisher: Informa Healthcare; 1 edition (August 1, 2001) Language: English ISBN-10: 1574911201 ISBN-13: 978-1574911206

Pharmaceutical Formulation Development of Peptides and Proteins (The Taylor & Francis Series in Pharmaceutical Sciences) [Hardcover]

Lars Hovgaard (Editor),

Product DescriptionThis comprehensive volume brings the different aspects of peptide and protein formulation into focus, beginning with the fundamentals of the production of peptides and proteins, ranging from synthesis to protein purification.

Product Details

Hardcover: 238 pages Publisher: CRC Press; 1 edition (December 16, 1999) Language: English ISBN-10: 0748407456 ISBN-13: 978-0748407453

SAS Programming in the Pharmaceutical Industry [Paperback]

Jack Shostak

(Author)

B001K8CN9W

Product DescriptionAt last! A real-world reference guide for clinical trial SAS programming, packed with solutions that programmers can apply to their day-to-day problems. Discover key techniques and tools available within Base SAS (including the macro language and PROC SQL), SAS/GRAPH, and SAS/STAT that can be used to resolve many common issues in working with clinical trial data. Organized to reflect the statistical programmer's work flow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. Valuable plug-and-play programming examples are provided throughout. Whether you're a novice seeking an introduction to SAS programming for the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, you'll find a wealth of practical suggestions to help you sharpen your skills.

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Product Details

Paperback: 360 pages Publisher: SAS Publishing; 1 edition (September 2005) Language: English ISBN-10: 1590477936 ISBN-13: 978-1590477939

Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Third Edition (Drugs and the Pharmaceutical Sciences) Louis Rey

Product Description

Freeze drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. This new edition of Freeze Drying/ Lyophilization of Pharmaceutical and Biological Products addresses these changes with updated and new chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this comprehensive text is a valuable resource for all those who use freeze drying technology.

Product Details

Hardcover: 640 pages Publisher: Informa Healthcare; 3 edition (June 15, 2010) Language: English ISBN-10: 1439825750 ISBN-13: 978-1439825754

Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy (Practical Spectroscopy) [Hardcover]

Emil W. Ciurczak

(Author)

B001JS64KM

Product DescriptionThis book discusses the theory, instrumentation, validation, and implementation of near-infrared spectroscopy for pharmaceutical and medical applications. It showcases a diverse range of contemporary methods for the production, screening, and analysis of new drug products and pharmaceuticals. Presents current approaches in near-infrared spectroscopy (NIR) to monitor and control multiple phases of the drug manufacturing process.

About the AuthorCadrai Technologies, Goldens Bridge, New York, USA United States Pharmacopeia, Rockville, Maryland, USA --This text refers to an alternate Hardcover edition.

Product Details

Hardcover: 208 pages Publisher: CRC Press; 1 edition (February 8, 2002) Language: English ISBN-10: 0824794532 ISBN-13: 978-0824794538

Pharmaceutical Chemical Analysis: Methods for Identification and Limit Tests

Ole Pedersen

(Author)

B001JS7SYI

Product Description

Complete, referenced information in an easy-to-use format

Many of the monographs in the European Pharmacopiea, the industry standard test for certain groups of ingredients and excipients, do not describe the tests in full, but reference general methods based on test-tube chemistry. When a test fails, you need to know what went wrong, how it can be fixed, and how to convince QA\QC that the tested material is okay. This gives you little time to dig out the relevant scientific literature, literature that is often so old it doesn’t show up in an electronic search.

Making this knowledge easily accessible and directly applicable to work in the lab, Pharmaceutical Chemical Analysis: Methods for Limit Tests and Identifications explains the purpose of these older tests, the chemistry involved, and hazards to avoid. The book covers the identification of ions and functional groups tests and limit tests respectively. It covers subjects relevant to all the pharmacopoeial identification/limit test and then goes on to describe the individual tests in chapters organized and named as they appear in the European Pharmacopoeia. Each chapter begins with a short discussion on the purpose and rationale of the tests, followed by a review of the physical and chemical characters of the target ion or compound. The author describes the chemical background and logic of the individual procedural steps of the test with formulas and reaction and provides tips on the strengths and weaknesses of these techniques in terms of specificity, ruggedness, and potential procedural pitfalls.

Strict regulatory requirements and economic pressures make the pharmaceutical industry understandably reluctant to replace a test that is simple, cheap, and performs well with expensive, unvalidated instrumental techniques. This resource bridges the gap by providing an in-depth understanding of the principles behind the European Pharmacopoeia tests and how to use them, saving you valuable production time.

Product Details

Hardcover: 176 pages Publisher: CRC Press (January 13, 2006) Language: English ISBN-10: 0849319781 ISBN-13: 978-0849319785

Pharmaceutical Drug Analysis [Hardcover]

Ashutosh Kar (Author)

Product DescriptionIn this specific context the remarkable proliferation of windows-based computer software stretched overwhelmingly towards instrument control, real time data handling abilities and the ultimate usage of Laboratory Information Management Systems (LIMS) are surprisingly noteworthy. "Pharmaceutical Drug Analysis" in its present form essentially comprise of six parts containing in all thirty-two well-elaborated chapters predominantly dealing with the set of descriptive analytical methodologies developed to control and assure the quality of the final marketed product; and, therefore, includes both qualitative and quantitative methods of analysis to help in the identification as well as purity of the product. The main purpose of this textbook is to discuss in an explicit and lucid manner several of the newer methods that now find rather wider application in the domain of pharmaceutical analysis. The basic principle of each technique is critically treated with emphasis on factors that directly affect its proper and judicious application to various analytical problems. An in-depth knowledge of these principles, instrumentations, modus operandi, experimental parameters, and sample preparation procedures in order to optimize the performance procedure of typical assay of pharmaceutical secondary products i.e., dosage forms, calculations etc., along with cognate assays from the Official Compendia have been included profusely. Undergraduate and postgraduate students of pharmaceutical drug analysis, quality assurance chemists, industrial trainees, bulk-drug professionals and those in related disciplines earnestly requiring a substantial fundamental understanding and knowledge of the subject will certainly find this a much needed suitable compilation for reading and reference. The broad coverage included in each of the selected analytical techniques would render "Pharmaceutical Drug Analysis" to be an useful source of ideas, inspiration for research, and developing newer practical solutions to problems in the ever expanding field of pharmaceutical analysis.

Product Details

Hardcover: 564 pages Publisher: New Age Publications (Academic) (December 1, 2006) ISBN-10: 8122416748 ISBN-13: 978-8122416749

Name Reactions and Reagents in Organic Synthesis [Hardcover]

Bradford P. Mundy

(Author), Michael G. Ellerd (Author), Frank G. Favaloro Jr. (Author)

B001HD04GE

Product DescriptionThis Second Edition is the premier name resource in the field. It provides a handy resource for navigating the web of named reactions and reagents. Reactions and reagents are listed alphabetically, followed by relevant mechanisms, experimental data (including yields where available), and references to the primary literature. The text also includes three indices based on reagents and reactions, starting materials, and desired products. Organic chemistry professors, graduate students, and undergraduates, as well as chemists working in industrial, government, and other laboratories, will all find this book to be an invaluable reference.

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Product Details

Hardcover: 904 pages Publisher: Wiley-Interscience; 2 edition (April 21, 2005) Language: English ISBN-10: 0471228540 ISBN-13: 978-0471228547

Design and Analysis of Animal Studies in Pharmaceutical Development (Chapman & Hall/CRC Biostatistics Series) [Hardcover]

Shein-Chung Chow (Editor), Jen-pei Liu (Editor)

Product Details

Hardcover: 424 pages Publisher: Chapman and Hall/CRC; 1 edition (January 15, 1998) Language: English ISBN-10: 0824701305 ISBN-13: 978-0824701307

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis

Leonard Steinborn

(Author

Product DescriptionVolume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.

Product Details

Ring-bound: 448 pages Publisher: Informa Healthcare; 6 edition (June 27, 2003) Language: English ISBN-10: 0849318467 ISBN-13: 978-0849318467

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition (2 Volume Set): GMP/ISO Quality Audit Manual for ...

B001KIFI1C

and Guidelines): Regulations Volume 2 [Paperback]

Leonard Steinborn

(Author)

Product details

Paperback: 452 pages Publisher: Informa Healthcare; 6th Revised edition edition (30 Dec 2004) Language English ISBN-10: 0849318475 ISBN-13: 978-0849318474

Advanced Practical Medicinal Chemistry [Paperback]

Ashutosh Kar (Author)

B001KIFI1C

About the AuthorAshutosh Kar is a well-known Professor of Pharmaceutical Chemistry, presently, teaching at Shri RNS College of Pharmacy, Gormi, Bhind (M.P.). He has to his credit twenty-seven years teaching experience at undergraduate and graduate levels both in Indian Universities and abroad. He has published more than twenty research papers based on pharmacological studies on natural and synthetic drugs in international and national scientific journals. He has taught at School of Pharmacy, Addis Ababa University, Addis Ababa (Ethiopia) (2002-2005); Guru Jhambheshwar University, Hisar (India) (1999-2002); Al-Arab Medical University, Benghazi, (Libya) (1997-1998); College of Pharmacy (University of Delhi), Delhi (India) (1990-1994); Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka (Nigeria) (1976-1987).

Product Details

Paperback: 330 pages Publisher: New Age Publications (Academic) (January 30, 2009) ISBN-10: 8122415393 ISBN-13: 978-8122415391

Chemical Analysis in the Laboratory: A Basic Guide [Paperback]

I. Mueller-Harvey

(Author

B001K7NCCU

Product DescriptionProvides basic training in the whole analytical process for students, demonstrating why analysis is necessary and how to take samples, before they attempt to carry out any analysis in the laboratory. Softcover.

Product Details

Paperback: 112 pages Publisher: Royal Society of Chemistry; 1 edition (September 10, 2002) Language: English ISBN-10: 0854046461 ISBN-13: 978-0854046461

Food Energy - Methods of Analysis And Conversion Factors [Paperback]

Bernan (Author

Paperback

Publisher: Bernan Assoc (March 2004)

Language: English

ISBN-10: 9251050147

ISBN-13: 978-9251050149

Bioanalytical Separations, Volume 4 (Handbook of Analytical Separations)

Editorial Reviews

Review"This is a well-written and informative volume. It brings the reader up to date on a wide range of issues pertaining to separation methods in bioanalysis with special emphasis on sample preparation and LC-MS... This book should be of high value for scientists working with drug analysis in biological fluids."Alexander Nezlin, The Alchemist, February 2004.

Book DescriptionVolume 4 of the multi-volume series, Handbook of Analytical Separations

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Product Details

Hardcover: 442 pages Publisher: Elsevier Science; 1 edition (September 17, 2003) Language: English ISBN-10: 0444506586 ISBN-13: 978-0444506580

Advances in Chromatography

Edited by Phyllis R. Brown

Price: $249.95 Binding/Format: Hardback ISBN: 978-0-8247-9361-6 Publish Date: January 20th 1995 Imprint: CRC Press Pages: 448 pages

Description

"Volume 35 examines timely subjects such as performance requirements, detection modes, and ancillary techniques for optical detectors in capillary electrophoresis; and more."

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Volume 5 (Separation Science and Technology) [Hardcover]

Satinder Ahuja (Author), Karen Mills Alsante (Author)

Product DescriptionThe United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized.

Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.

This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.

It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.

- Provides valuable information on isolation and characterization of impurities.- Gives a regulatory perspective on the subject.- Describes various considerations involved in meeting regulatory requirements.- Discusses various sources of impurities and degredation products.

See all Editorial Reviews

Product Details

Hardcover: 430 pages Publisher: Academic Press; 1 edition (August 1, 2003) Language: English ISBN-10: 012044982X ISBN-13: 978-0120449828

Drug-like Properties: Concepts, Structure Design and Methods: from ADME to Toxicity Optimization [Hardcover]

Edward Kerns

(Author), Li Di

(Author)

Product DescriptionOf the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, typically only a fraction of these have sufficient ADME/Tox properties to become a drug product. Understanding ADME/Tox is critical for all drug researchers, owing to its increasing importance in advancing high quality candidates to clinical studies and the processes of drug discovery. If the properties are weak, the candidate will have a high risk of failure or be less desirable as a drug product. This book is a tool and resource for scientists engaged in, or preparing for, the selection and optimization process.

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B001ILFMAI

The authors describe how properties affect in vivo pharmacological activity and impact in vitro assays. Individual drug-like properties are discussed from a practical point of view, such as solubility, permeability and metabolic stability, with regard to fundamental understanding, applications of property data in drug discovery and examples of structural modifications that have achieved improved property performance. The authors also review various methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties.

* Serves as an essential working handbook aimed at scientists and students in medicinal chemistry* Provides practical, step-by-step guidance on property fundamentals, effects, structure-property relationships, and structure modification strategies * Discusses improvements in pharmacokinetics from a practical chemist's standpoint

Product Details

Hardcover: 552 pages Publisher: Academic Press; 1 edition (February 19, 2008) Language: English ISBN-10: 0123695201 ISBN-13: 978-0123695208

Development of Biopharmaceutical Parenteral Dosage Forms (Drugs and the Pharmaceutical Sciences) [Hardcover]

Bontempo (Author)

Product DescriptionThis up-to-the-minute reference delineates;in a systematic fashion;the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products;covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

Product Details

Hardcover: 264 pages Publisher: Informa Healthcare; 1 edition (July 25, 1997) Language: English ISBN-10: 082479981X ISBN-13: 978-0824799816

Analytical Measurement Terminology: Handbook of Terms Used in Quality Assurance of Analytical Measurement (Valid Analytical Measurement) [Paperback]

E. Prichard (Author)

Product DescriptionThis unique handbook explains the most commonly used terminology and places each term in context. Concepts are described in a way that make them meaningful to practitioners and in line with ¿official definitions¿ developed by international organizations.

Product Details

Paperback: 86 pages Publisher: Royal Society of Chemistry; 1 edition (November 9, 2001) Language: English ISBN-10: 0854044434 ISBN-13: 978-0854044436