Introduction to FIH/Phase 1 Track

Authors: Dykstra, K
Conference: SLP MIDD+
Keywords: exposure, FIH/Phase I, FIHSimulator, SLP2021MIDD
Division: Clinical Pharmacology and Pharmacometrics (CPP)

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?

Later …

  • 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

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Presented at SLP MIDD+ Virtual Conference March 3-4, 2021