Using a population PK/PD model developed on phase I to select the dose for Phase II: an example with an IgG1 mAb
Keywords: dose, FIH/Phase I, PK/PD, SLP2021MIDDSoftware: Monolix®, Simulx™Conference: SLP MIDD+Division: Lixoft
Phase II dosing regimen
Dosing of 30 mg/kg Q4W could guarantee >90% inhibition of membrane-bound receptor for 9 in 10 individuals
- weight distribution is different?
- patients have reduced clearance due to the renal impairment?
- we start with a loading dose?
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By Monika Twarogowska
Presented at SLP MIDD+ Virtual Conference March 3-4, 2021