An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs

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/dr...
-----------------------
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/cd...
SBIA Listserv - public.govdeli...
SBIA 2022 Playlist - • 2022 CDER Small Busine...
SBIA LinkedIn -  / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cd...
Twitter -  / fda_drug_info
Email - [e-mail]
Phone - [phone] I [phone]