Introduction to FIH/Phase 1 Track
Application of Modeling & Simulation in Phase 1
Questions to be Addressed
First in Human Studies
- How much can we give safely?
- What is the human exposure?
- Does the drug engage with its target?
- What affects exposure?
–Other drugs? Food? Physiological impairment?
- How do we administer the drug?
–Exposure with new formulations
–Bridging among study populations
By Kevin Dykstra
Presented at SLP MIDD+ Virtual Conference March 3-4, 2021