Advancing Generic Drug Development: Translating Science to Approval – Day 2 – Session 5
This workshop focused on common issues seen in abbreviated new drug applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development, and pre-ANDA meeting discussions, and examined various areas of innovative science and cutting-edge methodologies behind generic drug development. This workshop also provided some insight into upcoming GDUFA III enhancements. Timestamps 02:24 – In-Vitro Binding Studies for Bioequivalence Demonstration 22:25 – Assessing API “Sameness” 42:40 – In Vitro Assessments that Support In Vitro Binding Studies in Demonstrating Bioequivalence of Locally Acting Gastrointestinal Drugs 58:55 – Common Deficiencies and Case Studies of In-Vitro Binding Bioequivalence Studies 1:15:58 – Session 5 Question & Answer Panel Session Leads: Wei-Jhe Sun, PhD Pharmacologist DTP II | ORS | OGD | CDER Nilufer Tampal, PhD Acting Associate Director of Scientific Quality OB | OGD | CDER Speakers: Hongmei Li, PhD Senior Pharmaceutical Quality Assessor LBB1 | DLBPI | OLDP | OPQ | CDER Manar Al-Ghabeish, PhD Staff Fellow DTP II | ORS | OGD | CDER Hongfei Zhou, PhD Pharmacologist DB III | OB | OGD | CDER Panelists: Wei-Jhe Sun, Hongmei Li, Manar Al-Ghabeish, and Hongfei Zhou Including: Hongling Zhang, PhD Division Director DB II | OB | OGD | CDER Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2022 Playlist - • 2022 CDER Small Business and Industry Assi... SBIA LinkedIn - / cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - / fda_drug_info Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367
