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• W1968177654 abstract "To verify the availability of pharmacokinetic parameters in cynomolgus monkeys, hepatic availability (<i>Fh</i>) and the fraction absorbed multiplied by intestinal availability (<i>FaFg</i>) were evaluated to determine their contributions to absolute bioavailability (<i>F</i>) after intravenous and oral administrations. These results were compared with those for humans using 13 commercial drugs for which human pharmacokinetic parameters have been reported. In addition, in vitro studies of these drugs, including membrane permeability, intrinsic clearance, and p-glycoprotein affinity, were performed to classify the drugs on the basis of their pharmacokinetic properties. In the present study, monkeys had a markedly lower <i>F</i> than humans for 8 of 13 drugs. Although there were no obvious differences in <i>Fh</i> between humans and monkeys, a remarkable species difference in <i>FaFg</i> was observed. Subsequently, we compared the <i>FaFg</i> values for monkeys with the in vitro pharmacokinetic properties of each drug. No obvious <i>FaF</i>g differences were observed between humans and monkeys for drugs that undergo almost no in vivo metabolism. In contrast, low <i>FaFg</i> were observed in monkeys for drugs that undergo relatively high metabolism in monkeys. These results suggest that first-pass intestinal metabolism is greater in cynomolgus monkeys than in humans, and that bioavailability in cynomolgus monkeys after oral administration is unsuitable for predicting pharmacokinetics in humans. In addition, a rough correlation was also observed between in vitro metabolic stability and <i>Fg</i> in humans, possibly indicating the potential for <i>Fg</i> prediction in humans using only in vitro parameters after slight modification of the evaluation system for in vitro intestinal metabolism." @default.
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• W1968177654 date "2009-11-12" @default.
• W1968177654 modified "2023-10-18" @default.
• W1968177654 title "A Comparison of Pharmacokinetics between Humans and Monkeys" @default.
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• W1968177654 doi "https://doi.org/10.1124/dmd.109.028829" @default.
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