Forced degradation studies are crucial in pharmaceutical development, providing insights into drug degradation pathways. These studies aid in developing stability-indicating methods (SIMs) and meeting regulatory expectations. A key element is evaluating mass balance (MB), which correlates degradation products with the loss of the parent compound. However, inconsistencies in MB measurement, calculation, and interpretation across the industry can challenge regulatory submissions, potentially delaying approvals.
This session, informed by the International Forced Degradation Community (IFDC) representing 10 major pharma companies, defines MB concepts, demonstrates calculation methods, and offers strategies for addressing suboptimal results. Using an Ishikawa diagram, we analyze how analytical methods, sample extraction, and degradation mechanisms affect MB outcomes.
Attendees will gain insights from a survey of 27 studies highlighting factors leading to poor MB. This session provides guidance for scientists and regulatory professionals to streamline regulatory submissions for small molecule drugs.
Learning Objectives:
Upon completion, participants will be able to critically assess and interpret mass balance data.
Upon completion, participants will be able to apply science-based calculation methods to quantify mass balance.
Upon completion, participants will be able to implement strategies to address poor outcomes, ensuring compliance with regulatory expectations.
