Sarem Sarem, Biostat Unit, Office of Science Therapeutic Products Directorate, Health Canada, presents his thoughts on MIDD, Pharmacometrics, and Modeling & Simulation approaches in Phase III of drug development.
Topics covered:
- Common model-informed drug development applications for regulatory submissions
- Understanding the benefits and risks of a drug for the intended use and patient population
- Good Data + Good Model + Good Analysis
- and more!
Presented at SLP MIDD+ Virtual Conference March 3-4, 2021
Disclaimer: This presentation reflects the views and thoughts of the author and should not be considered to represent Health Canada’s views or policies