School of Advanced Studies

Biowaivers,

development of in vitro-in vivo correlations

and quality generic drugs

Bucharest, Romania

July 9-11, 2014

Chair: Professor Mircioiu Constantin and Dr. Vinod P Shah

International Scientific Committee

Leslie Z Benet, USA

Vinod P. Shah, USA

Henning Blume, Germany

Nikoletta Fotaki, England

Atilla Hincal, Turkey

Imre Klebovich, Hungary

Vijay Kshirsagar, India

Reinhard Neubert, Germany

Christos Reppas, Greece

Panos Macheras, Greece

Milena Jadrijevic-Mladar Takacč, Croatia

Local Organizing Committee

Constantin Mircioiu, Bucharest

Sorin E. Leucuta, Cluj-Napoca

Victor A. Voicu, Bucharest

Dumitru Lupuleasa, Bucharest

Flavian Stefan Radulescu, Bucharest

Dalia Simona Miron, Bucharest

Valentina Anuta, Bucharest

Ion Mircioiu, Bucharest

~ Wednesday, July 9, 2014 ~

Introductory workshop: In Vitro and In Vivo Evaluations

09:00-09:30

Opening Welcome

SESSION 1A : BIOETHICAL ASPECTS OF BIOSTATISTICAL ANALYSIS

09:30-10:00

Ethical aspects of statistical analysis plan for the protocol of clinical studies

Barbara Schug, Germany

10:00-10:30

Alternative Methods to Laboratory Animals (ATLA)

Manuela Siderof

10:30 - 11:00

Coffee Break

11:00-11:30

Post-Trial Provisions Bioethics in biostatistical analysis

Aydin Erenmemisoglu, Turkey

11:30-12:00

Incertitude in statistical analysis

Constantin Mircioiu

12 :30-13 :00

Q and A

SESSION 1B: PRACTICAL ASPECTS OF INDUSTRIAL IN VITRO – IN VIVO RESEARCH AND CORRELATIONS ( coordinated by ERWEKA )

13:30-14:00

In-vitro setup, qualification procedures

14:00-14:30

Compendial requirements for developing and conducting

In vitro dissolution/ release studies

Flavian Radulescu

14:30 - 15:00

Data analysis. Evaluation of in-vitro dissolution/release similarity

15:30-16:00

In vitro - in vivo correlations, modeling and prediction

16 :30-17:00

Q and A

~ Thursday, July 10, 2014 ~

09:00-09:30

Opening Welcome

09:30-10:00

Bioequivalence and Drug Product Quality Vinod P. Shah, USA

10:00-10:30

Why generic drugs? What is the value/importance of generic drugs? Leslie Z Benet, USA

10:30-11:00

Coffee Break

11:00-11:30

BCS and Biowaivers

Vinod P. Shah, USA

11:30-12:00

BDDCS and its applications/implications

Leslie Z Benet, USA

12:00-12:30

Biowaiver applications in the European scenario

Carla M. Caramella, Italy

12:30-13:00

Q and A

13:00-14:00

Lunch

14:00-14:30

Dissolution test, its principles and compendial test

Nikoletta Fotaki, England

14:30-15:00

Biorelevant in vitro performance testing of orally administered products: What and Why? Christos Reppas, Greece

15:00-15:30

IVIVCs – traditional thru PBPK modeling Nikoletta Fotaki, England

15:30-16:00

Coffee Break

16:30-17:00

Convolution of release kinetics – IVIVC with metabolite Mircioiu Constantin, Romania

17:00-17:30

Q and A

~ Friday, July 11, 2014 ~

09:00-09:30

Implementation of QbD in manufacturing

Vijay Kshirsagar, India

09:30-10:00

In vitro experimental models by choosing the optimal oral dosage form Christos Reppas, Greece

10:00-10:30

Handling of out of specification results in dissolution testing Vijay Kshirsagar, India

10:30-11:00

Coffee Break

11:30-12:00

EMA: Consideration for locally acting drugs in the GI Tract

Henning Blume, Germany

12:00-12:30

Functions, liabilities, and responsibilities of parties in bioequivalence studies

Atilla Hincal, Turkey

12:30-13:00

Bioanalytical aspects of different in vitro in vivo interaction studies

Imre Klebovich, Hungary

13:00-14:00

Lunch

14:00-14:30

Percutaneous absorption Reinhard Neubert, Germany

14:30-15:00

In-vitro drug release from semisolid dosage forms Flavian Stefan Radulescu, Romania

15:00-15:30

The subcellular bioavailability as a new opportunity for drug targeting and efficacy

Sorin Emilian Leucuta, Romania

15:30-16:00

Closing Remarks