Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 1 - Part 1
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- Опубликовано: 21 окт 2024
- FDA experts demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in ANDAs alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA and ANDA meeting discussions.
Timestamps
00:49 - Keynote
19:28 - IVRT Methods for In Situ Depot-Forming Long-Acting Injectable Products
35:42 - Nano-Size Complex Products In Vitro Release Testing (IVRT)
49:13 - Application of Adaptive Perfusion as In Vitro Release Testing Method to Improve Understanding and Assessment of Complex Drug Products
01:05:03 - Session 1: Q&A Panel
Keynote:
Robert M. Califf, MD, MACC
Commissioner
U.S. Food and Drug Administration (FDA)
Session Leads:
Wenlei Jiang, PhD,
Senior Advisor for Innovation and Strategic Outreach
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD) | CDER
Yan Wang, PhD,
Lead Pharmacologist / Acting Deputy Division Director
Division of Therapeutic Performance I (DTP I)
ORS | OGD | CDER
Speakers | Panelists:
Agm (Abu) Mostofa, PhD
Pharmacologist
Division of Bioequivalence I (DBI)
Office of Bioequivalence (OB)
OGD | CDER
Thilak Mudalige, PhD
Research Chemist
Arkansas Human & Animal Food Laboratory (ARLHAF)
Office of Human & Animal Food Laboratory Operations (OHAFLO)
Office of Regulatory Science (ORS)
Office of Regulatory Affairs (ORA)
Dongkai Zhu, PhD
Visiting Associate
Division of Pharmaceutical Quality Research VI (DPQR VI)
Office of Pharmaceutical Quality Research (OPQR)
Office of Pharmaceutical Quality (OPQ) | CDER
Hee Sun Chung, PhD
Lead Pharmacologist
DBIDBI | OB | OGD | CDER
Xiaoming Xu, PhD
Division Director
Division of Pharmaceutical Quality Research V (DPQR V)
OPQR | OPQ | CDER
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