Abstract

Bioequivalence studies are fundamental in pharmaceutical research and regulatory evaluation, aiming to establish the equivalence of generic drugs to their branded counterparts. This article provides a comprehensive overview of the methodologies employed in bioequivalence studies, including study design, analytical techniques, and statistical analyses. It also discusses the applications of bioequivalence studies in generic drug approval, formulation development, and clinical practice. Key challenges and considerations, such as inter-individual variability and regulatory compliance, are addressed. The article concludes with insights into future directions for enhancing bioequivalence study methodologies.