Generics and Bioequivalence  book cover
1st Edition

Generics and Bioequivalence

Edited By

Andre J. Jackson

ISBN 9780367208325
Published January 6, 2022 by CRC Press
203 Pages

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Book Description

Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.

Table of Contents

1. Statistical Methods in Bioquivalence

Eric Ormsby

2. Role of Single- and Multiple Dose Studies in the Estimation of Bioquivalence

Andre J. Jackson

3. Role of Metabolites in Bioquivalency Assessment

Mei-Ling Chen and Andre J. Jackson

4. Analytical Aspects of Bioquivalency Testing

James Leslie

5. Pharmacodynamics and Bioquivalence

Nicholas H. G. Holford

6. In Vivo and In Vitro Correlations: Scientific and Regulatory Perspectives

Vinod P. Shah and Roger L. Williams

7. Stereochemical Considerations in Bioavailability Studies

William R. Ravis and Joel S. Owen

8. Animal Models and Their Role in Bioquivalence Studies

Wade J. Adams

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Andre J. Jackson Ph.D., is a reviewer at the U.S. Food and Drug Administration Office of Generic Drugs in the Center for Drug Evaluation and Research.