Pharmacometrics in Phase 1: First in Human and Dose Selection for Phase 2

Authors: Patel Y
Conference: SLP MIDD+
Keywords: dose selection, drug development, fih, FIH/Phase I, FIHSimulator, MIDD (model-informed drug development), SLP2021MIDD
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Outline

  • Drug development and Phase 1 studies
  • Application of MIDD during Phase 1 studies

–FIH dose selection

–Special populations

–Dose prediction for a different indication

–Proof of target engagement

By Yogesh Patel

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