The Role of Modeling & Simulation (M&S) in Regulatory Decision Making

Authors: Hawes J
Conference: SLP MIDD+
Keywords: clinical doses, dose, exposure-response curves, Pre-Clinical, SLP2021MIDD

Outline

  1. M&S Roles in Determining Clinical Doses
  2. M&S Influence on Nonclinical Bioassay Study Designs
  3. Dose-/Exposure-response Curves & Dose Escalation
  4. Reformulations
  5. Drug Accumulation Potential

By Jessica Hawes

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