Human Mass Balance (hADME)_Part 2 of 3 скачать в хорошем качестве

Human Mass Balance (hADME)_Part 2 of 3

Webinar presented on March 27, 2025. IQ Consortium Human Mass Balance (hADME) Working Group (WG) presented a webinar series dedicated to advancing the field of human mass balance studies. The WG's mission was to explore the conventional/historical 14C-hADME study design and opportunities to adopt modern alternatives, along with discussions around impact of the data produced and regulatory requirements around the globe. Guided by the expertise of its four subteams, this webinar series offered in-depth insights into the evolving landscape of hADME studies and their critical role in drug development. This session includes the following: 1. Regulatory Considerations for Human Radiolabeled Mass Balance Studies Across Different Regions (Camille Granvil & Ulrike Glaenzel) An analysis of hADME regulatory requirements across key regions, including United States (FDA), European Medicines Agency (EMA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), China's National Medical Products Administration (NMPA; CFDA), and Australia's Therapeutic Goods Administration (TGA). Furthermore, clinical pharmacology considerations regarding design and conduct of human mass balance studies across different regions and the variations in their interpretation. 2.Sample Pooling Strategies in hADME Studies (Proposal) (Filip Cuyckens & Wenying Li) A discussion of pooling strategy proposals for hADME studies to inform clinical pharmacologists, including the pros and cons of pooling in the analysis of samples from ADME studies (average vs. individual analysis) and flow charts highlighting the most recent thinking. 3.The Mixed Matrix Method (MmM) (Alex James) A discussion of the mixed matrix method (MmM) for sample bioanalysis highlighting its benefits for early metabolite assessment across species. Additionally, an overview of cross-industry validation and best practices as well as clinical pharmacology considerations for when to use traditional bioanalysis for metabolite monitoring. IQ Consortium Translational & ADME Sciences Leadership Group hADME Working Group Learn more at iqconsortium.org