Pharmacodynamic Endpoint Bioequivalence Studies

Pharmacodynamic (PD) studies can be used to establish bioequivalence of drug products when pharmacokinetic (PK) and in vitro studies are not applicable. Compared with clinical endpoint bioequivalence studies, PD studies are more cost-effective, timesaving, sensitive, less risky, and less complicated. In this chapter, we will discuss PD endpoint-based bioequivalence studies, the general considerations for PD study design and validation, and US Food and Drug Administration (FDA) recommendations for bioequivalence studies of specific drug products. Finally, the other potential PD endpoints reported in literatures for bioequivalence studies will be briefly discussed.