Pharmacometrics Phase 2 Proof-Of-Concept Dose Selection Phase 3/Marketing

Authors: Bihorel S
Conference: SLP MIDD+
Keywords: clinical trial simulation, MIDD (model-informed drug development), pharmacometrics, Phase II, SLP MIDD+ Virtual Conference, SLP2021MIDD, Workflow
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Sébastien Bihorel, Director, Pharmacometrics and Workflow Automation answers the question: “Where & how can pharmacometrics help?”

Topics covered:

  • Exposure-Response
  • Pharmacometrics Analyses
  • ​Model-based Power Approach
  • Clinical Trial Simulations
  • and more!

“Exposure-response information is at the heart of any determination of the safety and effectiveness of drugs” – ​FDA’s Guidance for Industry: Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications

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