Facilitating Generic Drug Product Development through Product-Specific Guidances

U.S. Food and Drug Administration
U.S. Food and Drug Administration
3.5 هزار بار بازدید - 4 ماه پیش - The purpose of this webinar
The purpose of this webinar was to provide current and prospective generic drug applicants insight on how PSGs are developed, revised, and published, and how PSGs may be used to improve the efficiency of generic drug development. Timestamps 05:08 – PSG Program: Updates and Overview of Available Resources 30:03 – Beyond General Guidance: Tailored PSG Recommendations for Immediate Release Oral Drug Products 45:15 – Development of Generic Drug Products Under Suitability Petition 57:50 – Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs 01:12:44 – Consideration Factors for Study Population Selection in Bioequivalence Studies with Pharmacokinetic Endpoints 01:28:00 – FDA Dissolution Methods and Navigating the Dissolution Database 01:38:14 – Panel Discussion 02:16:50 – Speaker Q&A Discussion Panel 02:56:03 – Closing Remarks Speakers | Panelists: Joseph Kotsybar, Pharm.D. Regulatory Health Project Manager Office of Research and Standards (ORS) Office of Generic Drugs (OGD) CDER | FDA Qi Zhang, Ph.D. Lead Pharmacologist Division of Therapeutic Performance II (DTP II) ORS | OGD | CDER | FDA Heather Boyce, Ph.D. Lead Pharmacokineticist DTP II | ORS | OGD | CDER | FDA Karthika Natarajan, Ph.D. Staff Fellow DTP I | ORS | OGD | CDER | FDA Jihong Shon, M.D., Ph.D. Senior Staff Fellow DTP II | ORS | OGD | CDER | FDA Leah W. Falade, Ph.D. Senior Pharmacologist Office of Product Quality Assessment II (OPQA II) Office of Pharmaceutical Quality (OPQ) CDER | FDA Robert Lionberger, Ph.D. Director ORS | OGD | CDER | FDA Dave Coppersmith, J.D. Regulatory Counsel Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) OGD | CDER | FDA Utpal Munshi, Ph.D. Division Director Division of Bioequivalence I (DBI) Office of Bioequivalence (OB) OGD | CDER | FDA Markham Luke, M.D., Ph.D. Division Director DTP I | ORS | OGD | CDER | FDA Myong-Jin Kim, Pharm. D. Division Director DTP II | ORS | OGD | CDER |FDA Liang Zhao, Ph.D. Division Director Division of Quantitative Methods and Modeling (DQMM) ORS | OGD | CDER | FDA Lei Zhang, Ph.D. Deputy Director ORS | OGD | CDER | FDA Learn more at: www.fda.gov/drugs/news-events-human-drugs/facilita… ----------------------- 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 - www.fda.gov/cdersbia SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/n… SBIA 2022 Playlist -    • 2022 CDER Small Business and Industry...   SBIA LinkedIn - www.linkedin.com/showcase/cder-small-business-and-… SBIA Training Resources - www.fda.gov/cdersbialearn Twitter - twitter.com/FDA_Drug_Info Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367
4 ماه پیش در تاریخ 1403/03/03 منتشر شده است.
3,571 بـار بازدید شده
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