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# ICH M15 Model-Informed Drug Development Principles
- URL: https://www.fdaweb.com/ich-m15-model-informed-drug-development-principles/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158408

FDA has published the International Council for Harmonization draft M15 guidance, *General Principles for Model-Informed Drug Development*, with general recommendations for planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD). The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m15-general-principles-model-informed-drug-development?ref=fdaweb.com) says it establishes a harmonized assessment framework, including associated terminology, for MIDD evidence.

For the guidance, it says, MIDD is defined as the strategic use of computational modeling and simulation methods that integrate nonclinical and clinical data, prior information, and knowledge to generate evidence.