Baseline variations in in vivo cytochrome P450 3A-dependent phenotypes evaluated using concentrations of endogenous or deuterium-labeled cortisol and their 6β-hydroxylated metabolites in 103 cynomolgus monkeys and 20 humanized-liver mice transplanted with hepatocytes.

Abstract excerpt

Drug exposure, in terms of plasma concentrations, may be affected by individual differences in intrinsic drug-metabolizing enzymes as much as by exogenous drug interactions. However, baseline variations in drug-metabolizing enzyme activities in normal subjects and acceptable ranges for these variations remain unclear. To elucidate these baseline variations, CYP3A-dependent endogenous cortisol and/or...

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