ABSTRACT
A bioequivalence clinical trial is a clinical trial that follows a protocol whose objective is to demonstrate that two (or more) formulations of the same drug are ‘‘bioequivalent.’’ Two formulations of the same drug are said to be bioequivalent if they have identical or comparable bioavailability. Bioavailability is thought of as the extent and rate to which the active drug (or active metabolite) gets into the bloodstream and is hence made available to tissue and the target organ.
