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# ICH Model-Informed Drug Development Guide Out
- URL: https://www.fdaweb.com/ich-model-informed-drug-development-guide-out/
- Published: 2024-12-10T12:00:00.000Z
- Updated: 2026-09-14T14:48:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158338

FDA has published an International Council for Harmonization draft M15 guideline, *General Principles for Model-Informed Drug Development*. The [document](https://database.ich.org/sites/default/files/ICH%5FM15%5FEWG%5FStep2%5FDraftGuideline%5F2024%5F1031.pdf?ref=fdaweb.com) provides general recommendations for planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD) and establishes a harmonized assessment framework, including associated terminology, for MIDD evidence.

The guidance defines MIDD as the “strategic use of computational modeling and simulation methods that integrate nonclinical and clinical data, prior information, and knowledge (e.g., drug and disease characteristics) to generate evidence.”

It contains an Introduction, Framework for Assessment of MIDD Evidence, Model Evaluation, MIDD Reporting and Submission, and three appendices.