Pharmacometrics in Phase 3 – Data Integration and Analysis to Support Dose and Labeling for the NDA

Authors: Passarell JA
Conference: SLP MIDD+
Keywords: analysis, Data Interpretation, dose, pharmacometrics, Phase III, SLP2021MIDD
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Characteristics of Phase 3?

  • Phase 3 studeis typically involve 300 to 3,000 participants from patient populations for which the medicine is eventually intended to be used
  • Participants are assigned to receive either the medication being evaluated or a control group that receives either the current standard of care treatment or a placebo
  • Phase 3 studies are diagnosed to:
    • demonstrate whether or not a drug candidate offers a treament benefit to a specific population
    • provide more detailed saftey data, and
    • serve as the basis for product labeling
  • Only 33% of drugs make it to Phase 3

By Julie A Passarell

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