Generics and Bioequivalence: 1st Edition (e-Book) book cover

Generics and Bioequivalence

1st Edition

Edited by Andre J. Jackson

CRC Press

203 pages

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eBook (VitalSource) : 9780429263644
pub: 2019-06-13
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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

About the Authors/Editor

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.

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Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / General
MEDICAL / Pharmacology
MEDICAL / Pharmacy
SCIENCE / Chemistry / Analytic