Bioequivalence Studies: Role In Enhancing the Quality of Pharmaceutical Pro Ducts

Abstract

Bioequivalence studies play a crucial role in enhancing the quality of pharmaceutical products. These
studies compare the performance of a test product with a reference product, ensuring no clinically significant difference in their bioavailability. These studies assess drug substance release, absorption, and concentration, providing insights into formulation
equivalence. They serve as indicators of generic drug effectiveness and safety, avoiding the need for extensive clinical trials.1 Bioequivalence studies apply not only to generics but also to innovator drugs in specific cases. Maintaining high manufacturing standards contributes to consistent quality, efficacy, and safety. The importance of these studies has grown with the
increase in generic product production and usage.