This webinar offered a deeper look into the draft guidance “Statistical Approaches to Establishing Bioequivalence” for new and revised content as well as provided clarification to comments received through the public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: www.fda.gov/drugs/news-events...
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6 авг 2024
