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