Prediction of Phase I single-dose pharmacokinetics using recombinant cytochromes P450 and physiologically based modelling.

1. Ten compounds from the Merck Research Laboratories pipeline were selected to evaluate the utility of using intrinsic clearance derived from recombinantly expressed cytochromes P450 (CYP) and physiologically based pharmacokinetic modelling to predict Phase I pharmacokinetics using simCYP®. The compounds selected were anticipated to be eliminated predominantly by P450 metabolism. 2. There was a reasonable agreement between the predicted and actual clinical exposure with 80% of the predicted exposures […]

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