Workshop 6 Modeling and Simulation to help …

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Modelling and Simulation to help define MABEL and starting dose in FIH studiesB Laurijssens, BEL Pharm W Martin, Pharmacometrics Group, Dept Clinical Pharmacology, Pfizer, Sandwich Labs, Kent, 2How should we select a starting dose ?Base the starting dose on toxicology in animalsBase the starting dose on Pharmacology in animalsBase the starting dose on toxicology in animals and expected pharmacology in humansSlide 3What is the right thing to do ? accurately predict exposure in humans Scaling to man should use state of the art approaches PK scaling to humans of Pharmacology in Humans (MABEL) Inter-species differences in binding, relative time ( normalized to lifespan), signalling or pathway differences should be taken into account relationship in animals Need to take account of NOAEL To estimate a safety margin All predictions are relative to observed toxicology Pharmacology usually evident prior to a Safety Margin/Factor to predicted

Modelling and simulation to help define MABEL and Starting dose in FIH studies B Laurijssens, BEL Pharm Consulting. Steven W Martin, Pharmacometrics Group, Dept Clinical Pharmacology,

  Dose, Starting, Starting dose, Mbale