Generics and Bioequivalence

✍ Scribed by Andre J. Jackson (Editor)

Publisher: CRC Press
Year: 1994
Leaves: 216
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

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

✦ Subjects

Bioscience;Pharmaceutical Science;Analysis & Pharmaceutical Quality;Pharmacy

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