Opportunities for Drug Development Dynamic Tools

Participants at a 5/2-5/3/2024 public discussion hosted by FDA and the Center for Research on Complex Generics on “Pathways for Regulatory Acceptance of Dynamic Tools in the New Drug Space” found that model-based approaches like physiologically-based pharmacokinetics and population pharmacokinetics, when validated for their context of use, can serve as regulatory assets by facilitating efficient drug development. An FDA report on the workshop was published in Pharmaceutical Research.

“The broader potential for reusing validated models across multiple programs including Fit-For-Purpose and Model Master File present significant opportunities and complementary benefits for improving regulatory efficiency and decision-making,” the report says. It says the workshop underscored the importance of clear regulatory pathways and structured frameworks for the consistent application of reusable models.