Beth Ludwig, Associate Vice President, Quantitative Clinical Pharmacology, gives a brief introduction to the application of Modeling & Simulation in Phase 3 – questions to be addressed, speakers, and presentations.
- Do the intended dose(s) demonstrate the desired safety and efficacy in the population?
- Is the dose likely to change in a given subpopulation or special population? If so, by how much?
Presented at SLP MIDD+ Virtual Conference March 3-4, 2021