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  4. An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations - 10/26/2022
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Event Title
An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
October 26, 2022

October 26, 2022

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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


  • 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


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


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

2:20 - 2:40: Break

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


Final Guidance for Industry: Bioavailability Studies Submitted in NDAs or INDs — General Considerations


Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


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