February 12, 2020
Speaker: Carol M. Galvis
Educational Levels: Foundational, Practical

This webinar will provide an overview of safety assessment of metabolites in drug development. The speaker will discuss relevant guidance documents and will describe important considerations for the safety assessment of drug metabolites, including type of studies required and timing of submission to regulatory Agencies. This topic has evolved over the last few years and the speaker will incorporate FDA recent case studies that will provide participants insight into the regulatory decision-making process regarding this topic. Examples will include unique human metabolites, disproportionate human metabolites, metabolites that are acyl glucuronides, and examples of safety assessment of drug metabolites for severe, debilitating, and life-threatening (SDLT) conditions.