Abstract: International audience; The derivation of the optimal design for an upcoming toxicokinetic study of butadiene in humans is presented. The specific goal of the planned study is to obtain a precise estimate of butadiene metabolic clearance for each study subject, together with a good characterization of its population variance. We used a two-compartment toxicokinetic model, imbedded in a hierarchical population model of variability, in conjunction with a preliminary set of butadiene kinetic data in humans, as a basis for design optimization. Opti...
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Topics: 
Statistics
Simulation
Biological system