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  4. A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence - 03/14/2023
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Virtual | Virtual

Event Title
A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
March 14, 2023


Date:
March 14, 2023
Time:
10:00 AM - 12:00 PM ET

Topic & Presentations

Speakers

FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence 

 

Introduction

Liang Zhao, PhD
Director
Division of Quantitative Methods and Modeling (DQMM)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)

Overview (Contents of the Guidance)

Stella C. Grosser, PhD
Director
Division of Biometrics VIII (DB VIII)
Office of Biostatistics (OB)
Office of Translational Sciences (OTS)

Statistical Test for Population Bioequivalence

Sungwoo Choi, PhD
Mathematical Statistician
DB VIII | OB | OTS

Statistical Approaches to Establishing Bioequivalence – Specific Situations: An Overview of In Vitro Release Test (IVRT), In Vitro Permeation Test (IVPT), and Earth Mover’s Distance (EMD) comparative studies

Kimberly Raines, PhD
Branch Chief
Division of Biopharmaceutics (DB)
Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ)

Statistical Methods for Narrow Therapeutic Index and Highly Variable Drug Products

Donald Schuirmann, MS
Expert Mathematical Statistician
DB VIII | OB | OTS

Comparative Clinical Endpoint Bioequivalence Studies

Fairouz Makhlouf, PhD
Deputy Director
DB VIII | OB | OTS

Bioequivalence Studies in Multiple Groups

Wanjie Sun, PhD
Lead Mathematical Statistician
DB VIII | OB | OTS

Adapted Design for Bioequivalence Studies

Wanjie Sun, PhD

Bioequivalence Statistics for Adhesion and Irritation Studies

Somesh Chattopadhyay, PhD
Lead Mathematical Statistician
DB VIII | OB | OTS

Dose Scale Analysis to Support Bioequivalence Assessment

Meng Hu, PhD
Team Lead
DQMM | ORS | OGD

Recommendations in the 2022 Revised Bioequivalence Statistical Guidance and Bioequivalence Assessments

Zhen Zhang, PhD
Senior Pharmacologist
Office of Bioequivalence (OBI)
Division of Bioequivalence I (DB I)
OGD

Q&A Panel Discussion

Speakers mentioned above 

Including:

Lanyan (Lucy) Fang, PhD
Deputy Director
DQMM | ORS | OGD

Ying Fan, PhD
Lead Pharmacologist
Division of Clinical Review (DCR)
Office of Safety and Clinical Evaluation (OSCE)
OGD

 

Agenda

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ABOUT THIS WEBINAR

In December 2022, FDA issued a draft guidance for industry entitled Statistical Approaches to Establishing Bioequivalence, which provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. This guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches generally and in specific situations. When finalized, this guidance will replace the February 2001 FDA guidance for industry “Statistical Approaches to Establishing Bioequivalence” and will represent FDA’s current thinking on this topic.

This webinar will take a deeper look into the draft guidance for new and revised content and provide clarification to comments received through the public docket.

TOPICS COVERED

  • In Vitro Bioequivalence assessment
  • Statistical Methods for Narrow Therapeutic Index and Highly Variable Drug Products
  • Comparative Clinical Endpoint Bioequivalence Studies
  • Studies in Multiple Groups
  • Bioequivalence Statistics for Adhesion and Irritation Studies
  • Dose Scale for Bioequivalence Assessment

LEARNING OBJECTIVES

  • Provide an overview of the draft guidance
  • Describe the major changes in the draft guidance from the 2001 guidance
  • Provide clarification and rationale on selected topics to address comments received

INTENDED AUDIENCE

  • Generic and new drug industry, including current and potential applicants who are interested in submitting an application for a generic drug or a new drug
  • Regulatory reviewers for generic and new drug development and assessments
  • Researchers working on generic drugs and new drugs
  • Consultants focused on bioequivalence
  • Clinical research coordinators
  • Healthcare professionals specializing in prescribing and dispensing medications
  • Foreign regulators

FDA RESOURCES

 
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