An Overview of the Draft ICHM15 Guideline on Model-Informed Drug Development
Автор: ISOP CHANNEL
Загружено: 2025-02-25
Просмотров: 600
In November 2024, the ICH Assembly endorsed the draft guideline entitled “M15 General Principles for Model-Informed Drug Development” and agreed to make the guideline available for public comment. This marks a major milestone for model-informed drug development (MIDD) and its maturity as a globally accepted standard for evidence generation. The draft guideline is the product of the multidisciplinary Expert Working Group (EWG) of the ICH. It establishes a harmonized assessment framework (including associated terminology) for MIDD evidence and provides an assessment table as a tool for communication. In this session, members of the ICH M15 EWG from regulatory agencies and industry will provide an overview of the draft guideline. The presentations will cover key contents of the M15 guideline, relevant perspectives, and examples.
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