Optimizing sample size of a phase III trial with Simulx using a phase II popPD model

Authors: Magnard C
Conference: SLP MIDD+
Keywords: Asthma, clinical trial, MIDD (model-informed drug development), MonolixSuite Playlist, Phase II, simulx, SLP MIDD+ Virtual Conference, SLP2021MIDD
Software: Monolix®, Simulx®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Goal: design of a bridging study

Reference asthma treatment

  • Current standard-of-care
  • Approved globally (also in China)

New asthma treatment

  • FDA approved
  • does not include Chinese patients

By Claude Magnard

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