Publication Cover
Xenobiotica
the fate of foreign compounds in biological systems
Volume 47, 2017 - Issue 12
1,926
Views
37
CrossRef citations to date
0
Altmetric
General Xenobiochemistry

Comparison of predictability for human pharmacokinetics parameters among monkeys, rats, and chimeric mice with humanised liver

, , , , &
Pages 1052-1063 | Received 10 Oct 2016, Accepted 22 Nov 2016, Published online: 02 Mar 2017

References

  • Akabane T, Gerst N, Masters JN, Tamura K. (2012a). A quantitative approach to hepatic clearance prediction of metabolism by aldehyde oxidase using custom pooled hepatocytes. Xenobiotica 42:863–71
  • Akabane T, Gerst N, Naritomi Y, et al. (2012b). A practical and direct comparison of intrinsic metabolic clearance of several non-CYP enzyme substrates in freshly isolated and cryopreserved hepatocytes. Drug Metab Pharmacokinet 27:181–91
  • Akabane T, Tabata K, Kadono K, et al. (2010). A comparison of pharmacokinetics between humans and monkeys. Drug Metab Dispos 38:308–16
  • Baldock GA, Brodie RR, Chasseaud LF, et al. (1991). Pharmacokinetics of benzydamine after intravenous, oral, and topical doses to human subjects. Biopharm Drug Dispos 12:481–92
  • Banker MJ, Clark TH, Williams JA. (2003). Development and validation of a 96-well equilibrium dialysis apparatus for measuring plasma protein binding. J Pharm Sci 92:967–74
  • Bowalgaha K, Miners JO. (2001). The glucuronidation of mycophenolic acid by human liver, kidney and jejunum microsomes. Br J Clin Pharmacol 52:605–9
  • Cutler DJ. (1978). Theory of the mean absorption time, an adjunct to conventional bioavailability studies. J Pharm Pharmacol 30:476–8
  • Dalvie D, Xiang C, Kang P, Zhou S. (2013). Interspecies variation in the metabolism of zoniporide by aldehyde oxidase. Xenobiotica 43:399–408
  • Dalvie D, Zhang C, Chen W, et al. (2010). Cross-species comparison of the metabolism and excretion of zoniporide: contribution of aldehyde oxidase to interspecies differences. Drug Metab Dispos 38:641–54
  • Davies B, Morris T. (1993). Physiological parameters in laboratory animals and humans. Pharm Res 10:1093–5
  • Dedrick RL. (1973). Animal scale-up. J Pharmacokinet Biopharm 1:435–61
  • Deguchi T, Watanabe N, Kurihara A, et al. (2011). Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach. Drug Metab Dispos 39:820–9
  • Deppe S, Boger RH, Weiss J, Benndorf RA. (2010). Telmisartan: a review of its pharmacodynamic and pharmacokinetic properties. Expert Opin Drug Metab Toxicol 6:863–71
  • Duggan DE, Hogans AF, Kwan KC, Mcmahon FG. (1972). The metabolism of indomethacin in man. J Pharmacol Exp Ther 181:563–75
  • Engel G, Hofmann U, Heidemann H, et al. (1996). Antipyrine as a probe for human oxidative drug metabolism: identification of the cytochrome P450 enzymes catalyzing 4-hydroxyantipyrine, 3-hydroxymethylantipyrine, and norantipyrine formation. Clin Pharmacol Ther 59:613–23
  • European Medicines Agency. (2009). European Medicined Agency approval document: assessment report for CONBRIZA. Procedure No. EMEA/H/C/913, 1-49, EMEA/CHMP/660889/2008
  • Fisher MB, Yoon K, Vaughn ML, et al. (2002). Flavin-containing monooxygenase activity in hepatocytes and microsomes: in vitro characterization and in vivo scaling of benzydamine clearance. Drug Metab Dispos 30:1087–93
  • Hosea NA, Collard WT, Cole S, et al. (2009). Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches. J Clin Pharmacol 49:513–33
  • Houston JB. (1994). Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance. Biochem Pharmacol 47:1469–79
  • Hutzler JM, Cerny MA, Yang YS, et al. (2014). Cynomolgus monkey as a surrogate for human aldehyde oxidase metabolism of the EGFR inhibitor BIBX1382. Drug Metab Dispos 42:1751–60
  • Hutzler JM, Obach RS, Dalvie D, Zientek MA. (2013). Strategies for a comprehensive understanding of metabolism by aldehyde oxidase. Expert Opin Drug Metab Toxicol 9:153–68
  • Hutzler JM, Yang YS, Albaugh D, et al. (2012). Characterization of aldehyde oxidase enzyme activity in cryopreserved human hepatocytes. Drug Metab Dispos 40:267–75
  • Ito K, Houston JB. (2004). Comparison of the use of liver models for predicting drug clearance using in vitro kinetic data from hepatic microsomes and isolated hepatocytes. Pharm Res 21:785–92
  • Ito K, Iwatsubo T, Kanamitsu S, et al. (1998). Quantitative prediction of in vivo drug clearance and drug interactions from in vitro data on metabolism, together with binding and transport. Annu Rev Pharmacol Toxicol 38:461–99
  • Iwatsubo T, Hirota N, Ooie T, et al. (1997). Prediction of in vivo drug metabolism in the human liver from in vitro metabolism data. Pharmacol Ther 73:147–71
  • Kato K, Ohbuchi M, Hamamura S, et al. (2015). Development of murine Cyp3a knockout chimeric mice with humanized liver. Drug Metab Dispos 43:1208–17
  • Katoh M, Matsui T, Nakajima M, et al. (2004). Expression of human cytochromes P450 in chimeric mice with humanized liver. Drug Metab Dispos 32:1402–10
  • Katoh M, Matsui T, Okumura H, et al. (2005). Expression of human phase II enzymes in chimeric mice with humanized liver. Drug Metab Dispos 33:1333–40
  • Kawashima K, Hosoi K, Naruke T, et al. (1999). Aldehyde oxidase-dependent marked species difference in hepatic metabolism of the sedative-hypnotic, zaleplon, between monkeys and rats. Drug Metab Dispos 27:422–8
  • Kaye B, Offerman JL, Reid JL, et al. (1984). A species difference in the presystemic metabolism of carbazeran in dog and man. Xenobiotica 14:935–45
  • Kilford PJ, Stringer R, Sohal B, et al. (2009). Prediction of drug clearance by glucuronidation from in vitro data: use of combined cytochrome P450 and UDP-glucuronosyltransferase cofactors in alamethicin-activated human liver microsomes. Drug Metab Dispos 37:82–9
  • Kinzig-Schippers M, Fuhr U, Zaigler M, et al. (1999). Interaction of pefloxacin and enoxacin with the human cytochrome P450 enzyme CYP1A2. Clin Pharmacol Ther 65:262–74
  • Klotz U, Antonin KH, Bieck PR. (1976). Proceedings: hepatic elimination of diazepam and its active metabolites. Arzneimittelforschung 26:1235–6
  • Koyanagi T, Yamaura Y, Yano K, et al. (2014). Age-related pharmacokinetic changes of acetaminophen, antipyrine, diazepam, diphenhydramine, and ofloxacin in male cynomolgus monkeys and beagle dogs. Xenobiotica 44:893–901
  • Lang DH, Rettie AE. (2000). In vitro evaluation of potential in vivo probes for human flavin-containing monooxygenase (FMO): metabolism of benzydamine and caffeine by FMO and P450 isoforms. Br J Clin Pharmacol 50:311
  • Lautala P, Ethell BT, Taskinen J, Burchell B. (2000). The specificity of glucuronidation of entacapone and tolcapone by recombinant human UDP-glucuronosyltransferases. Drug Metab Dispos 28:1385–9
  • Lemoine A, Gautier JC, Azoulay D, et al. (1993). Major pathway of imipramine metabolism is catalyzed by cytochromes P-450 1A2 and P-450 3A4 in human liver. Mol Pharmacol 43:827–32
  • Lombardo F, Waters NJ, Argikar UA, et al. (2013a). Comprehensive assessment of human pharmacokinetic prediction based on in vivo animal pharmacokinetic data, part 2: clearance. J Clin Pharmacol 53:178–91
  • Lombardo F, Waters NJ, Argikar UA, et al. (2013b). Comprehensive assessment of human pharmacokinetic prediction based on in vivo animal pharmacokinetic data, part 1: volume of distribution at steady state. J Clin Pharmacol 53:167–77
  • Long L, Berg SL, Roy SK, et al. (2000). Plasma and cerebrospinal fluid pharmacokinetics of O6-benzylguanine and analogues in nonhuman primates. Clin Cancer Res 6:3662–9
  • Mano Y, Usui T, Kamimura H. (2007). Contribution of UDP-glucuronosyltransferases 1A9 and 2B7 to the glucuronidation of indomethacin in the human liver. Eur J Clin Pharmacol 63:289–96
  • Miners JO, Knights KM, Houston JB, Mackenzie PI. (2006). In vitro-in vivo correlation for drugs and other compounds eliminated by glucuronidation in humans: pitfalls and promises. Biochem Pharmacol 71:1531–9
  • Moise PA, Birmingham MC, Schentag JJ. (2000). Pharmacokinetics and metabolism of moxifloxacin. Drugs Today (Barc) 36:229–44
  • Mordenti J. (1986). Man versus beast: pharmacokinetic scaling in mammals. J Pharm Sci 75:1028–40
  • Nakajima M, Inoue T, Shimada N, et al. (1998). Cytochrome P450 2C9 catalyzes indomethacin O-demethylation in human liver microsomes. Drug Metab Dispos 26:261–6
  • Naritomi Y, Terashita S, Kimura S, et al. (2001). Prediction of human hepatic clearance from in vivo animal experiments and in vitro metabolic studies with liver microsomes from animals and humans. Drug Metab Dispos 29:1316–24
  • Obach RS. (1999). Prediction of human clearance of twenty-nine drugs from hepatic microsomal intrinsic clearance data: an examination of in vitro half-life approach and nonspecific binding to microsomes. Drug Metab Dispos 27:1350–9
  • Obach RS, Baxter JG, Liston TE, et al. (1997). The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 283:46–58
  • Obach RS, Lombardo F, Waters NJ. (2008). Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds. Drug Metab Dispos 36:1385–405
  • Ogawa K, Kato M, Houjo T, Ishigai M. (2013). A new approach to predicting human hepatic clearance of CYP3A4 substrates using monkey pharmacokinetic data. Xenobiotica 43:468–78
  • Plunkett W, Huang P, Xu YZ, et al. (1995). Gemcitabine: metabolism, mechanisms of action, and self-potentiation. Semin Oncol 22:3–10
  • Pryde DC, Dalvie D, Hu Q, et al. (2010). Aldehyde oxidase: an enzyme of emerging importance in drug discovery. J Med Chem 53:8441–60
  • Roy SK, Korzekwa KR, Gonzalez FJ, et al. (1995). Human liver oxidative metabolism of O6-benzylguanine. Biochem Pharmacol 50:1385–9
  • Sanoh S, Horiguchi A, Sugihara K, et al. (2012a). Prediction of in vivo hepatic clearance and half-life of drug candidates in human using chimeric mice with humanized liver. Drug Metab Dispos 40:322–8
  • Sanoh S, Naritomi Y, Fujimoto M, et al. (2015). Predictability of plasma concentration-time curves in humans using single-species allometric scaling of chimeric mice with humanized liver. Xenobiotica 45:605–14
  • Sanoh S, Nozaki K, Murai H, et al. (2012b). Prediction of human metabolism of FK3453 by aldehyde oxidase using chimeric mice transplanted with human or rat hepatocytes. Drug Metab Dispos 40:76–82
  • Sanoh S, Ohta S. (2014). Chimeric mice transplanted with human hepatocytes as a model for prediction of human drug metabolism and pharmacokinetics. Biopharm Drug Dispos 35:71–86
  • Scheer N, Wilson ID. (2016). A comparison between genetically humanized and chimeric liver humanized mouse models for studies in drug metabolism and toxicity. Drug Discov Today 21:250–63
  • Shibata Y, Takahashi H, Chiba M, Ishii Y. (2002). Prediction of hepatic clearance and availability by cryopreserved human hepatocytes: an application of serum incubation method. Drug Metab Dispos 30:892–6
  • Tateno C, Yoshizane Y, Saito N, et al. (2004). Near completely humanized liver in mice shows human-type metabolic responses to drugs. Am J Pathol 165:901–12
  • Thiel C, Schneckener S, Krauss M, et al. (2015). A systematic evaluation of the use of physiologically based pharmacokinetic modeling for cross-species extrapolation. J Pharm Sci 104:191–206
  • Tserng KY, Ingalls ST, Boczko EM, et al. (2003). Pharmacokinetics of O6-benzylguanine (NSC637037) and its metabolite, 8-oxo-O6-benzylguanine. J Clin Pharmacol 43:881–93
  • Undevia SD, Innocenti F, Ramirez J, et al. (2008). A phase I and pharmacokinetic study of the quinoxaline antitumour Agent R(+)XK469 in patients with advanced solid tumours. Eur J Cancer 44:1684–92
  • U.S. Food and Drug Administration. (1996). FDA approval package document: clinical pharmacology and biopharmaceutics review. Application number: 020624
  • U.S. Food and Drug Administration. (1995). FDA approval package document: division of oncology and pulmonary drug products review and evaluation of pharmacology and toxicology data original review. NDA: 20-509
  • Wang H, Zrada M, Anderson K, et al. (2014). Understanding and reducing the experimental variability of in vitro plasma protein binding measurements. J Pharm Sci 103:3302–9
  • 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 32:603–11

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.