The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp

chapter 1|14 pages

Introduction—Bioequivalence Issues

ByIsadore Kanfer, Leon Shargel

chapter 3|16 pages

Pharmaceutical Alternatives: Considerations for Generic Substitution

ByRoderick B. Walker, Roger K. Verbeeck, Isadore Kanfer

chapter 4|24 pages

Pharmacodynamic Measurements for Determination of Bioequivalence

ByManish Issar, Jeffrey G. Stark, Leon Shargel

chapter 5|26 pages

Bioequivalence Using Clinical Endpoint Studies

ByChristopher Hendy

chapter 6|26 pages

Evaluation of Bioequivalence of Highly Variable Drugs

ByLaszlo Endrenyi, Laszlo Tothfalusi

chapter 8|28 pages

Population Pharmacokinetic Approaches for Assessing Bioequivalence

ByPhilippe Colucci, Jean-Francois Marier, Murray P. Ducharme

chapter 9|14 pages

Role of Metabolites in Bioequivalence Assessment

ByAndre´ Jackson

chapter 10|22 pages

Implications of Chirality for the Assessment of Bioequivalence

ByReza Mehvar, Fakhreddin Jamali

chapter 11|26 pages

Effect of Food on Bioavailability and the Assessment of Bioequivalence

ByKim Dalhoff, Isadore Kanfer

chapter 12|24 pages

Bioequivalence Assessment of Endogenous Drug Substances: Pharmacokinetics and Statistical Evaluation

ByPhilippe Colucci, Marika Pasternyk-Di Marco, Diane Potvin, Murray P. Ducharme