Transcription of Workshop 6 Modeling and Simulation to help …
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Workshop 6 Modeling and Simulation to help …
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, 2 How 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 3 What 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 dose To ensure the safety and wellbeing of subjects in the trialSlide 44.
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,
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