Clinical Trials

■■❚❙❘Chapter 13Bioequivalence TrialsDuolao Wang, Radivoj Arezina,and Ameet BakhaiBioequivalence studies are, by and large, conducted to comparea generic drug preparation with a currently marketed formulation– typically an innovator drug product. In a bioequivalence study,blood samples are collected just before the administration ofa drug and for a period of time after administration. The drugconcentrations are then plotted against time in order to derivepharmacokinetic parameters and evaluate the bioequivalenceof the drugs under study. In this chapter, we describe some ofthe practical issues involved in the design and evaluation ofbioequivalence studies and show how inappropriate designof such studies can lead to erroneous conclusions.119