Pharmaceutical & Bioscience Society (PBSS): Human Mass Balance and Metabolite Profiling Studies: Strategies, Technical Approaches, Regulatory Guidance, Applications and Case Studies

This workshop is designed to provide detailed guidance on objectives, study designs, and data analysis of metabolism studies of small molecules. Speakers of this workshop bring a wealth of knowledge from the pharmaceutical industry/FDA in drug metabolism sciences. This workshop will describe the highlights of this regulatory guidance and various strategies and technical approaches for conducting the human radiolabeled ADME studies with examples of approved drugs.