The European Medicines Agency (EMA) is preparing to release draft guidance on how to assess and report new mechanistic models, aiming to encourage their wider use in model-informed drug development (MIDD).
The guidance will focus on promoting a standardized approach to the application of these models in the drug development process. A draft concept paper has been released for public consultation, running from 14 February 2025 to 31 May 2025. The paper outlines the development of a guideline for the assessment and reporting of mechanistic models, which play a key role in MIDD.
The concept paper is available for review here: EMA Concept Paper on Mechanistic Models
Models covered by this new guideline include, but are not limited to:
These models are crucial in simulating and predicting drug behavior within the human body, making them integral to the advancement of personalized medicine and more efficient drug development.
