Drug Evaluation Committee Evaluation of Model Credibility in Drug Development
Data Science Subcommittee
April 2025
The Drug Evaluation Committee's Data Science Subcommittee Continuing Task Force 4 in FY2024 focused on Model Credibility Assessment, which is one of the focal points of ICH M15 (General Principles for Model-Informed Drug Development). In the Step 2 document, the term "Assessment of MIDD (Model-Informed Drug Development) Evidence" is used as a synonym. In this document, we have organized the historical background and specifics of the Model Credibility evaluation. In addition, we investigated how and from what perspective Model Credibility evaluations are conducted by the FDA. We hope that this report will help you to understand and disseminate ICH M15 in particular.
Japan Pharmaceutical Manufacturers Association
Drug Evaluation Committee Data Science Subcommittee
Continuing Task Force 4 in FY2024
Deliverables of the Drug Evaluation Committee Return to list of all deliverables