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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)
Key Takeaways
  • The European Medicines Agency has given stakeholders until 31 May to comment on its plan to develop guidance relating to mathematical or computer models used in the context of model-informed drug development.
  • The guidance would cover physiologically based pharmacokinetic models, physiologically based biopharmaceutics models and quantitative systems pharmacology models, among other things.
  • It is needed to help the EMA confidently assess and quantify the potential risks associated with decisions based on these mechanistic models, ensuring informed and accurate outcomes.

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...

These mechanistic models, which integrate biopharmaceutical, physico mechanical, (patho)physiological and pharmacological processes, along with population characteristics, are frequently and increasingly used in all phases of the drug research and development...

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