FDA provided additional clarity to the final guidance with respect to Agency expectations for submissions containing BA information for drug products.
Timestamps
00:27 - Opening Comments
03:37 - Bioavailability Studies Submitted in NDAs and INDs - General Considerations
24:33 - Bioavailability Determination: Special Topics
50:08 - Relative Bioavailability Evaluation: Potential for Using Pharmacodynamic and Non-Traditional Pharmacokinetic Endpoints
1:10:57 - Recommended In Vitro Studies
1:40:40 - Q&A Discussion with All Presenters
Speakers:
Ethan Stier, PhD.
Associate Director, Lifecycle Management
Immediate Office (IO) | Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER
Dakshina Chilukuri, PhD.
Team Leader
Division of Infectious Disease Pharmacology (DIDP) | OCP| CDER
Jayabharathi Vaidyanathan, PhD.
Associate Director for Therapeutic Review
Division of Cardiometabolic and Endocrine Pharmacology (DCEP) | OCP| CDER
Kofi A. Kumi, Ph.D., R. Ph.
Senior Reviewer, Clinical Pharmacology
Division of Neuropsychiatric Pharmacology (DNP) | OCP | OTS | CDER
Okponanabofa Eradiri, PhD
Branch Chief
Division of Biopharmaceutics (DP) | Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ) | CDER | FDA
Panelists:
Ethan Stier, Dakshina Chilukuri, Jayabharathi Vaidyanathan, Kofi A. Kumi, and Okponanabofa Eradiri
Learn more at: www.fda.gov/drugs/news-events...
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26 окт 2022
