Bioequivalence Studies

Abstract

Bioequivalence studies are designed with the aimto compare the relative bioavailability between ageneric drug (test formulation) and the original orinnovative drug (reference formulation) by meansof the assessment of the ratio of the main pharmacokinetic parameters peak plasma concentration(Cmax) and area under the curve of plasma concentrations (AUC) in order to ensure therapeuticequivalence of both medicines.Relative bioavailability and bioequivalence areclosely related to the pharmaceutical development, and particularly to different aspects of themanufacturing process of solid pharmaceuticalforms. A drug contained in a solid pharmaceuticalform requires from the release and the subsequentabsorption and distribution at the target site toexert its pharmacological effect. For most drugs,the degree of the pharmacological effect willdepend on the plasma concentrations and thelevel of drug reached at the site of action; inother words, it depends on the rate and the amountof drug absorbed.