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Xenobiotica
the fate of foreign compounds in biological systems
Volume 43, 2013 - Issue 5
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Animal Pharmacokinetics and Metabolism

A new approach to predicting human hepatic clearance of CYP3A4 substrates using monkey pharmacokinetic data

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Pages 468-478 | Received 01 Aug 2012, Accepted 21 Sep 2012, Published online: 15 Nov 2012

References

  • Akabane T, Tabata K, Kadono K, Sakuda S, Terashita S, Teramura T. (2010). A comparison of pharmacokinetics between humans and monkeys. Drug Metab Dispos 38:308–316.
  • Berlin A, Dahlström H. (1975). Pharmacokinetics of the anticonvulsant drug clonazepam evaluated from single oral and intravenous doses and by repeated oral administration. Eur J Clin Pharmacol 9:155–159.
  • Boxenbaum H. (1982). Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharmacokinet Biopharm 10:201–227.
  • Boxenbaum H. (1984). Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab Rev 15:1071–1121.
  • Brøsen K, Davidsen F, Gram LF. (1990). Quinidine kinetics after a single oral dose in relation to the sparteine oxidation polymorphism in man. Br J Clin Pharmacol 29:248–253.
  • Chao P, Uss AS, Cheng KC. (2010). Use of intrinsic clearance for prediction of human hepatic clearance. Expert Opin Drug Metab Toxicol 6:189–198.
  • Crevoisier C, Delisle MC, Joseph I, Foletti G. (2003). Comparative single-dose pharmacokinetics of clonazepam following intravenous, intramuscular and oral administration to healthy volunteers. Eur Neurol 49:173–177.
  • Davies B, Morris T. (1993). Physiological parameters in laboratory animals and humans. Pharm Res 10:1093–1095.
  • Echizen H, Eichelbaum M. (1986). Clinical pharmacokinetics of verapamil, nifedipine and diltiazem. Clin Pharmacokinet 11:425–449.
  • Greenblatt DJ, Wright CE. (1993). Clinical pharmacokinetics of alprazolam. Therapeutic implications. Clin Pharmacokinet 24:453–471.
  • Hallifax D, Houston JB. (2009). Methodological uncertainty in quantitative prediction of human hepatic clearance from in vitro experimental systems. Curr Drug Metab 10:307–321.
  • Hallifax D, Foster JA, Houston JB. (2010). Prediction of human metabolic clearance from in vitro systems: retrospective analysis and prospective view. Pharm Res 27:2150–2161.
  • Hosea NA, Collard WT, Cole S, Maurer TS, Fang RX, Jones H, Kakar SM, Nakai Y, Smith BJ, Webster R, Beaumont K. (2009). Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches. J Clin Pharmacol 49:513–533.
  • Houston JB. (1994). Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance. Biochem Pharmacol 47:1469–1479.
  • Howgate EM, Rowland Yeo K, Proctor NJ, Tucker GT, Rostami-Hodjegan A. (2006). Prediction of in vivo drug clearance from in vitro data. I: impact of inter-individual variability. Xenobiotica 36:473–497.
  • Iwatsubo T, Hirota N, Ooie T, Suzuki H, Shimada N, Chiba K, Ishizaki T, Green CE, Tyson CA, Sugiyama Y. (1997). Prediction of in vivo drug metabolism in the human liver from in vitro metabolism data. Pharmacol Ther 73:147–171.
  • Komori M, Kikuchi O, Sakuma T, Funaki J, Kitada M, Kamataki T. (1992). Molecular cloning of monkey liver cytochrome P-450 cDNAs: similarity of the primary sequences to human cytochromes P-450. Biochim Biophys Acta 1171:141–146.
  • Lavé T, Chapman K, Goldsmith P, Rowland M. (2009). Human clearance prediction: shifting the paradigm. Expert Opin Drug Metab Toxicol 5:1039–1048.
  • Mahmood I, Balian JD. (1996). Interspecies scaling: predicting clearance of drugs in humans. Three different approaches. Xenobiotica 26:887–895.
  • Obach RS, Baxter JG, Liston TE, Silber BM, Jones BC, MacIntyre F, Rance DJ, Wastall P. (1997). The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 283:46–58.
  • Ohtsuka T, Yoshikawa T, Kozakai K, Tsuneto Y, Uno Y, Utoh M, Yamazaki H, Kume T. (2010). Alprazolam as an in vivo probe for studying induction of CYP3A in cynomolgus monkeys. Drug Metab Dispos 38:1806–1813.
  • Palma-Aguirre JA, Rosas-Alcázar G, Rodríguez JM, León-Urrea F, Montoya-Cabrera MA. (1989). Bioavailability and pharmacokinetics of nifedipine administered by different routes in healthy volunteers. Arch Invest Med (Mex) 20:129–135.
  • Rashid TJ, Martin U, Clarke H, Waller DG, Renwick AG, George CF. (1995). Factors affecting the absolute bioavailability of nifedipine. Br J Clin Pharmacol 40:51–58.
  • Shimada T, Mimura M, Inoue K, Nakamura S, Oda H, Ohmori S, Yamazaki H. (1997). Cytochrome P450-dependent drug oxidation activities in liver microsomes of various animal species including rats, guinea pigs, dogs, monkeys, and humans. Arch Toxicol 71:401–408.
  • Shiran MR, Proctor NJ, Howgate EM, Rowland-Yeo K, Tucker GT, Rostami-Hodjegan A. (2006). Prediction of metabolic drug clearance in humans: in vitro-in vivo extrapolation vs allometric scaling. Xenobiotica 36:567–580.
  • Thummel KE, O’Shea D, Paine MF, Shen DD, Kunze KL, Perkins JD, Wilkinson GR. (1996). Oral first-pass elimination of midazolam involves both gastrointestinal and hepatic CYP3A-mediated metabolism. Clin Pharmacol Ther 59:491–502.
  • Ueda CT, Williamson BJ, Dzindzio BS. (1976). Absolute quinidine bioavailability. Clin Pharmacol Ther 20:260–265.
  • Uehara S, Murayama N, Nakanishi Y, Zeldin DC, Yamazaki H, Uno Y. (2011). Immunochemical detection of cytochrome P450 enzymes in liver microsomes of 27 cynomolgus monkeys. J Pharmacol Exp Ther 339:654–661.
  • Uno Y, Hosaka S, Matsuno K, Nakamura C, Kito G, Kamataki T, Nagata R. (2007). Characterization of cynomolgus monkey cytochrome P450 (CYP) cDNAs: is CYP2C76 the only monkey-specific CYP gene responsible for species differences in drug metabolism? Arch Biochem Biophys 466:98–105.
  • Uno Y, Matsushita A, Osada N, Uehara S, Kohara S, Nagata R, Fukuzaki K, Utoh M, Murayama N, Yamazaki H. (2010). Genetic variants of CYP3A4 and CYP3A5 in cynomolgus and rhesus macaques. Drug Metab Dispos 38:209–214.
  • Venkatakrishnan K, Culm KE, Ehrenberg BL, Harmatz JS, Corbett KE, Fleishaker JC, Greenblatt DJ. (2005). Kinetics and dynamics of intravenous adinazolam, N-desmethyl adinazolam, and alprazolam in healthy volunteers. J Clin Pharmacol 45:529–537.
  • Ward KW, Smith BR. (2004). A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans. I. Clearance. Drug Metab Dispos 32:603–611.
  • Ward KW, Nagilla R, Jolivette LJ. (2005). Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human. Xenobiotica 35:191–210.
  • Williams JA, Hyland R, Jones BC, Smith DA, Hurst S, Goosen TC, Peterkin V, Koup JR, Ball SE. (2004). Drug-drug interactions for UDP-glucuronosyltransferase substrates: a pharmacokinetic explanation for typically observed low exposure (AUCi/AUC) ratios. Drug Metab Dispos 32:1201–1208.

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