Joel Owen, Vice President of Pharmacometric Services, gives a brief introduction to the application of Modeling & Simulation in Phase 2 – questions to be addressed, speakers, and presentations.
- Can we develop predictive quantitative models for safety and efficacy endpoints?
- Can we confirm mechanisms of action; clinical utility and validation potential of biomarkers?
- What is the best dose and study design for the subsequent Phase 3 trials?
Presented at SLP MIDD+ Virtual Conference March 3-4, 2021