Drug Evaluation Committee Model Credibility Assessment in Drug Development
April 2025
The Data Science Subcommittee of the Drug Evaluation Committee’s FY2024 Continuing Task Force 4 focused on the assessment of model credibility, which is also one of the key areas addressed in ICH M15 (General Principles for Model-Informed Drug Development).Although the Step 2 document uses the term “Assessment of MIDD (Model-Informed Drug Development) Evidence,” we consider this to be a synonym.In this deliverable, we have organized information ranging from the historical background of model credibility assessment to its specific details. Furthermore, we investigated how the FDA conducts model credibility assessments, including the types of cases involved and the perspectives from which these assessments are performed. In particular, we hope this will aid in the understanding and dissemination of ICH M15.
Japan Pharmaceutical Manufacturers Association (JPMA)
Drug Evaluation Committee, Data Science Subcommittee
FY2024 Continuing Task Force 4