ICH M15 Draft Guideline on Model-Informed Drug Development

The Draft ICH M15 Guideline on General Principles for Model-Informed Drug Development (MIDD) reached Step 2a/b and was endorsed by the ICH Assembly. The document is expected to provide general recommendations for planning, model evaluation, and documentation of MIDD derived evidence. Furthermore, the paper includes a harmonized assessment framework with associated terminology.

Background and Scope

Drug development is a sequential and iterative process where MIDD can play an important role. When MIDD evidence may contribute to the answer to questions of interest, early planning allows the data to be generated to be incorporated into the overall drug development plan. It is expected that new questions of interest may emerge, and the associated plan could evolve as data and knowledge accumulate. However, "some of these iterations may require engagement with regulatory authorities to gain alignment on the MIDD planning", the document says.

According to ICH M15, MIDD is defined as the strategic use of computational modeling and simulation methods (e.g. Agent-based models, Artificial intelligence / machine learning) that integrate nonclinical and clinical data, prior information, and knowledge (e.g., drug and disease characteristics) to generate evidence. The guideline applies to both current and emerging modeling and simulation methods and applications. However, the document does not include details regarding technical aspects of model development. 

The draft ICH M15 guideline is composed of a core document including sections on the Framework for MIDD Evidence Assessment, Model Evaluation and MIDD Reporting and Submission and the following 3 Appendices:

• Appendix 1: Table for MIDD Evidence Assessment
• Appendix 2: Report Content  
• Appendix 3: Glossary

For more information please visit the ICH Multidisciplinary Guidelines website.