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ICH M15 Guideline: General Principles for Model-informed Drug Development
The integration of modeling and simulation into drug development has evolved from a supportive analytical tool to a central pillar of regulatory decision-making. Recognising this shift, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use has formally adopted ICH M15: Guideline on General Principles for Model-Informed Drug Development (MIDD) at Step 5 . The guideline was: Endorsed under Step 2 on 6 November 2024 Adopted by r

Sharan Murugan
Feb 152 min read


EMA Concept Paper: Guideline on Mechanistic Models in Model-Informed Drug Development (MIDD)
The European Medicines Agency (EMA) has released a concept paper proposing the development of a guideline for the assessment and...

Sharan Murugan
Feb 22, 20252 min read
