Comparative dissolution profiling of generic and standard drug under BCS Based Biowaiver conditions

Abstract

As specified by regulatory bodies, the current study intends to investigate the dissolving characteristics of a generic medicine product and its matching standard reference medication under Biowaiver settings. Through this comprehensive analysis, we validate the suitability of the generic drug for Biowaiver considerations. Consequently, it may potentially serve as a cost-effective alternative with therapeutic equivalence to the standard reference drug. These findings emphasize the significance of dissolution profiling in supporting the assessment of pharmaceutical quality and regulatory decision-making. This review paper also provides an overview of methodologies and statistical techniques used to compare dissolution profiles, which is a critical aspect of pharmaceutical quality assessment. The study investigates various approaches, including model-independent and model-dependent methods, in line with regulatory guidelines for evaluating whether the dissolution profiles are equivalent or comparable. We discuss the significance of choosing suitable metrics and acceptability criteria, and the effects of process and formulation modifications on dissolving profiles. The study's findings show that dissolving profiles are similar, suggesting that the generic drug's formulation satisfies the requirements to be eligible for Biowaiver. Therefore, it possesses potential for substitution with the standard drug under appropriate circumstances.