Drug Evaluation Committee Theory and Practice of Model-based Meta Analysis in Drug Development
The Data Science Subcommittee of the Drug Evaluation Committee’s FY2025 Continuing Task Force 4 focused on the application of Model-Based Meta-Analysis (MBMA), a topic for which there are few Japanese-language publications.This document introduces the theory of MBMA using mathematical formulas for experts, as well as the various ways MBMA can be utilized in drug development—from early to late stages—using typical case studies, for a broader audience of drug development professionals. We hope this will contribute to a proper understanding of MBMA and its appropriate use in drug development in Japan.
Japan Pharmaceutical Manufacturers Association (
) Drug Evaluation Committee, Data Science Subcommittee (
) FY2025 Continuing Task Force 4
Theory and Practice of Model-based Meta Analysis in Drug Development