Capture.JPGModel-Informed Drug Development Pilot Program

Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources

  • Quantitative methods to balance risks/benefits of drugs in development
  • Can improve clinical trial efficiency, increase probability of regulatory success, optimize drug dosing/therapeutic individualization without dedicated trials

Goals of the MIDD Pilot Program

  • Discuss application of MIDD approaches to development and regulatory evaluation of medical products
  • Provide advice about how particular MIDD approaches can be used in a specific drug development program

LEARN

Published by Drug & Device Advisory Group


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