M15 Resource Center
ICH M15 General Principles for Model-Informed Drug Development is intended to facilitate a multidisciplinary understanding of model-informed drug development (MIDD) and associated evidence generation to assist with drug development and regulatory decisions. The guidance describes the principles of MIDD, including recommendations on MIDD planning, model evaluation, and evidence documentation. The guidance also establishes a harmonized framework for assessing evidence derived from MIDD and provides recommendations for MIDD-related regulatory interactions, reporting, and submission. FDA recommends using this guidance when preparing documents for the Agency, including meeting requests, background packages, and regulatory submissions.