Generics and Bioequivalence

Provides an in-depth analysis of the many complex issues encountered in the determination of drug equivalence. The book includes updates on many controversial and emerging areas in the design and analysis of bioavailability and bioequivalence studies. Topics presented include the role of single and multiple dosing in the determination of bioequivalence, the role of metabolites in assessing bioequivalence and the use of animal models and statistics.