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The major aim of this study was to develop a strategy for predicting human pharmacokinetics using physiologically based pharmacokinetic (PBPK) modelling. This was compared with allometry (of plasma concentration-time profiles using the Dedrick approach), in order to determine the best approaches and strategies for the prediction of human pharmacokinetics.

PBPK and Dedrick predictions were made for 19 F. Hoffmann-La Roche compounds. A strategy for the prediction of human pharmacokinetics using PBPK modelling was proposed in this study. Predicted values (pharmacokinetic parameters, plasma concentrations) were compared with observed values obtained after intravenous and oral administration in order to assess the accuracy of the prediction methods.

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