In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A

Presentations and a panel consider the utility of in vitro characterization and modeling approaches to support biowaivers for certain non-Q1/Q2 formulations of prospective generic products. Presentations include, “Mechanistic Assessment of Excipient Changes for Biopharmaceutics Classification System (BCS) 1 Class and 3 Drug Products” and “BCS Class 3 Compounds: In Vivo Experience with Non-Q1/Q2 Formulations.”
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fy-2021-generic-drug-science-and-research-initiatives-public-workshop-06232021-06232021
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Видео In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A канала U.S. Food and Drug Administration