Using a population PK/PD model developed on phase I to select the dose for Phase II: an example with an IgG1 mAb

Authors: Twarogowska M
Conference: SLP MIDD+
Keywords: dose, FIH/Phase I, PK/PD, SLP2021MIDD
Software: Monolix®, Simulx®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Phase II dosing regimen

Dosing of 30 mg/kg Q4W could guarantee >90% inhibition of membrane-bound receptor for 9 in 10 individuals

But…what if

  • weight distribution is different?
  • patients have reduced clearance due to the renal impairment?
  • we start with a loading dose?
  • …

Go faster and win with Simulx

By Monika Twarogowska

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