Impact of MIDD During Phase II New Drug Development a Regulatory Perspective

Authors: Wang Y
Conference: SLP MIDD+

Yaning Wang, Division of Pharmacometrics, Office of Clinical Pharmacology, OTS/CDER/OMTP/FDA, discusses the impact of MIDD during Phase 2 of new drug development.

Topics covered:

  • Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations
  • Objectives of an EOP2A meeting
  • Advancing model-informed drug development
  • and more!

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Presented at SLP MIDD+ Virtual Conference March 3-4, 2021

Disclaimer: This presentation reflects the views of the presenter and should not be construed to represent those of the FDA or the United States Government.