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.
1. Statistical Methods in Bioquivalence
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
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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