Post on 30-May-2018
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IND
INVESTIGATIONALNEW DRUG APPLICATION
PRESENTED BY : ASHWANI GOYAL
M.PHARMACY 1ST SEMESTER
CHITKARA SCHOOL OF PHARMACY
CHITKARA UNIVERSITY
Himuda Educational Hub
Barotiwala
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Important Terms1.Sponsor: A manufacturer or a person or a party who wants to
with commercialization and selling of a product.
2.FDA: Food and Drug authority.
3.CDER: Centre for drug evaluation and research (USA).
4.CDSCO: Central Drug Standardisation and Control Organisat
5.Investigator: A person or a team which plans, coordinates and
clinical study of new drugs on humans executed.
6.Preclinical studies: Initial pharmacological studies done on afind efficacy, safety and toxicity and whether they can be utiliz
human studies.
7.Clinical studies/Trials: Pharmacological studies done on limi
number of human volunteers after a positive preclinical repor
efficacy, safety and toxicity on human use and establish dosag
and treatment methods.
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WHAT IS IND?
The IND is the means through which the sponsor technically ob
exemption from the FDA.
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TYPES OF IND
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IND CATEGORIES
1. COMMERCIAL
2. RESARCH (NON COMMERCIAL)
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IND APPLICATION MU
CONTAINS INFORMATABOUT
1. ANIMAL PHARMACOLOGY AND TOXIXOLOGY ST
2. MANUFACTURIN INFORMATION.
3. CLINICAL PROTOCOLS AND INVESTIGATORS
INFORMATION.
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IND APPLICATION
PROCEDURE
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yes
NO
continued
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Chemistry reviewers address issues related to drug identity, manuf
control, and analysis. The reviewing chemist evaluates the manufa
processing procedures for a drug to ensure that the compound is ad
reproducible and stable.
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Following review of an initial IND submission, CDER has 30 cale
which to decide if a clinical hold is necessary.
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DETAILS REQUIRED TO
PROVIDED WITH IND
APPLICATION
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This should be submitted to assure the pr
identification, quality, purity, and strengt
investigational drug.It includes information about-
1.Chemistry and Manufacturing introduc
2.Drug substance.
3.Drug Product.
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