U.S. Food and Drug Administration

FDA will provide additional clarity to the final guidance with respect to Agency expectations for submissions containing BA information for drug products, and will:

• Discuss select case studies on various bioavailability (BA) related subtopics (e.g. pharmacodynamic (PD) endpoints, endogenous compound Narrow Therapeutic Index (NTI), biowaivers).
• Conduct a QnA panel to make available an opportunity for attendees to interact with subject matter experts

INTENDED AUDIENCE

• Regulatory Scientists assessing bioavailability studies as part of IND/NDA/BLA submissions
• Research Coordinators overseeing in vivo studies in the context of IND/NDA/BLA submissions
• Drug Development/New Drug industry scientists involved with bioavailability studies for support of a new/existing IND/NDA/BLA dossier.
• Foreign regulators

TOPICS COVERED

• General BA considerations
• Pre/post approval changes
• In-vitro/in silico approaches to BA
• Alcohol considerations in relative BA

FDA SPEAKERS

1:00 - 1:10: SBIA Welcome and Overview

1:10 - 1:20: Opening Comments
Ethan Stier, PhD.
Associate Director, Lifecycle Management
Immediate Office (IO) | Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER

1:20 - 1:50: Bioavailability Studies Submitted in NDAs and INDs – General Considerations
Dakshina Chilukuri, PhD.
Team Leader
Division of Infectious Disease Pharmacology (DIDP) | OCP| CDER

1:50 - 2:20: Bioavailability Determination: Special Topics
Jayabharathi Vaidyanathan, PhD.
Associate Director for Therapeutic Review
Division of Cardiometabolic and Endocrine Pharmacology (DCEP) | OCP| CDER

2:40 - 3:10: Relative Bioavailability Evaluation: Potential for Using Pharmacodynamic and Non-Traditional Pharmacokinetic Endpoints
Kofi A. Kumi, Ph.D., R. Ph.
Senior Reviewer, Clinical Pharmacology
Division of Neuropsychiatric Pharmacology (DNP) | OCP | OTS | CDER

3:10 - 3:40: Recommended In Vitro Studies
Okponanabofa Eradiri, PhD
Branch Chief
Division of Biopharmaceutics (DP) | Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ) | CDER | FDA

3:40 - 4:00: Q&A Discussion with All Presenters

FDA RESOURCES