Generics and Bioequivalence

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.

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