1. Introduction : bioequivalence issues / Isadore Kanfer and Leon Shargel -- 2. Approved drug products with therapeutic equivalence evaluations (the orange book) / Loren Gelber -- 3. Pharmaceutical alternatives : considerations for generic substitution / Roderick B. Walker, Roger K. Verbeeck, and Isadore Kanfer -- 4. Pharmacodynamic measurements for determination of bioequivalence / Manish Issar, Jeffrey G. Stark, and Leon Shargel -- 5. Bioequivalence using clinical endpoint studies / Christopher Hendy -- 6. Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi -- 7. Statistical considerations : alternate designs and approaches for bioequivalence assessments / Stanford Bolton and Charles Bon -- 8. Population pharmokinetic approaches for assessing bioequivalence / Philippe Colucci, Jean-Francois Marier, and Murray P. Ducharme -- 9. Role of metabolites in bioequivalence assessent / Andre Jackson -- 10. Implications of chirality for the assessment of bioequivalence / Reza Mehvar and Fakhreddin Jamali -- 11. Effect of food on bioavailability and the assessment of bioequivalence / Kim Dalhoff and Isadore Kanfer -- 12. Bioequivalence assessment of endogenous drug substances : pharmacokinetics and statistical evaluation / Philippe Colucci. [et al.].