RATIONAL DRUG USE: CHOOSING BETWEEN GENERIC AND BRANDED MEDICINES

Abstract

Generic medications are essential for lowering medical expenses while preserving therapeutic efficacy on par with name-brand medications. With a focus on bioequivalence assessment and reporting quality, the examined publications collectively explore the scientific, regulatory, economic, and policy aspects of generic medicine use. Pharmacokinetic characteristics like area under the curve (AUC) and maximum plasma concentration (Cmax) are used in bioequivalence studies, which serve as the regulatory basis for generic medicine approval by organizations like the FDA and EMA. Nonetheless, a number of studies point out serious shortcomings in the completeness and transparency of reporting, such as the failure to adequately disclose funding sources, trial sites, randomization procedures, and regulatory requirements. Despite these limitations, the majority of trials conclude bioequivalence, supporting the clinical interchangeability of generic and innovator products