This webinar offered a deeper look into the draft guidance “Statistical Approaches to Establishing Bioequivalence” for new and revised content as well as provided clarification to comments received through the public docket.

Timestamps

04:27 – Introduction

09:10 – Overview (Contents of the Guidance)

16:00 – Statistical Test for Population Bioequivalence

21:35 – 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

27:37 – Statistical Methods for Narrow Therapeutic Index and Highly Variable Drug Products

39:50 Comparative Clinical Endpoint Bioequivalence Studies

50:10 – Bioequivalence Studies in Multiple Groups

55:45 – Adapted Design for Bioequivalence Studies

01:00:23 – Bioequivalence Statistics for Adhesion and Irritation Studies

01:09:28 – Dose Scale Analysis to Support Bioequivalence Assessment

01:20:36 – Recommendations in the 2022 Revised Bioequivalence Statistical Guidance and Bioequivalence Assessments

01:29:47 – Q&A Panel Discussion

Speakers:

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

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

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

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

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

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

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

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

Meng Hu, PhD
Team Lead
DQMM | ORS | OGD

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

Panelists:

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

Learn more at: https://www.fda.gov/drugs/newsevents...



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