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EMA Invites Feedback on Model-Informed Drug Development Standards

 
• By Neena Brizmohun

The European Medicines Agency believes its plan to develop guidance for reporting and evaluating mechanistic models used for MIDD would also benefit from input from other regulatory agencies, such as those in the US, Japan and Canada.

Female Research Scientist with Bioengineer Working on a Personal Computer with Screen Showing DNA Analysis Software User Interface. Scientists
Mechanistic models are increasingly being used in all phases of the drug research and development life cycle (Shutterstock)

The European Medicines Agency is seeking feedback on its plan to develop guidance that it hopes will set the standards for reporting and evaluating mathematical or computer models that are used in the context of model-informed drug development (MIDD).

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