Publication Cover
Xenobiotica
the fate of foreign compounds in biological systems
Volume 49, 2019 - Issue 12
783
Views
11
CrossRef citations to date
0
Altmetric
General Xenobiochemistry

Prediction of human pharmacokinetics of long half-life compounds using chimeric mice with humanised liver

, , , , , & show all
Pages 1379-1387 | Received 01 Dec 2018, Accepted 03 Feb 2019, Published online: 18 Mar 2019

References

  • Almond DS, Szwandt IS, Edwards G, et al. (2000). Disposition of intravenous pyrimethamine in healthy volunteers. Antimicrob Agents Chemother 44:1691–3.
  • Anastasiou-Nana M, Levis GM, Moulopoulos S. (1982). Pharmacokinetics of amiodarone after intravenous and oral administration. Int J Clin Pharmacol Ther Toxicol 20:524–9.
  • Bjornsson TD, Meffin PJ ,Swezey S, et al. (1979). Clofibrate displaces warfarin from plasma proteins in man: an example of a pure displacement interaction. J Pharmacol Exp Ther 210:316–21.
  • Carter BL, Ernst ME, Cohen JD. (2004). Hydrochlorothiazide versus chlorthalidone: evidence supporting their interchangeability. Hypertension 43:4–9.
  • Choisy H, Millart H. (1980). [Experimental pharmacology of probucol (author’s transl)]. Nouv Presse Med 9:2981–4.
  • European medicines agency: European medicines agency approval document: Assessment Report EMEA/H/C/001141
  • Fournier T, Medjoubi NN, Porquet D. (2000). Alpha-1-acid glycoprotein. Biochim Biophys Acta 1482:157–71.
  • Fuse E, Kuwabara T, Sparreboom A, Sausville EA, et al. (2005). Review of UCN-01 development: a lesson in the importance of clinical pharmacology. J Clin Pharmacol 45:394–403.
  • Fuse E, H, Tanii N, Kurata H, et al. (1998). Unpredicted clinical pharmacology of UCN-01 caused by specific binding to human alpha1-acid glycoprotein. Cancer Res 58:3248–53.
  • Fuse E, H, Tanii K, Takai K, et al. (1999). Altered pharmacokinetics of a novel anticancer drug, UCN-01, caused by specific high affinity binding to alpha1-acid glycoprotein in humans. Cancer Res 59:1054–60.
  • Hoke JF, Dyker AG, Barnaby RJ, Lees KR. (2000). Pharmacokinetics of a glycine site antagonist (gavestinel) following multiple dosing in patients with acute stroke. Eur J Clin Pharmacol 55:867–72.
  • Holford NH. (1986). Clinical pharmacokinetics and pharmacodynamics of warfarin. Understanding the dose-effect relationship. Clin Pharmacokinet 11:483–504.
  • Holt DW, Tucker GT, Jackson PR, Storey GC. (1983). Amiodarone pharmacokinetics. Am Heart J 106:840–7.
  • 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.
  • Hurwitz HI, Dowlati A, Saini S, et al. (2009). Phase I trial of pazopanib in patients with advanced cancer. Clin Cancer Res 15:4220–7.
  • Inoue T, Sugihara K, Ohshita H, et al. (2009). Prediction of human disposition toward S-3H-warfarin using chimeric mice with humanized liver. Drug Metab Pharmacokinet 24:153–60.
  • Kamimura H, Ito S, Chijiwa H, Okuzono T, et al. (2017). Simulation of human plasma concentration-time profiles of the partial glucokinase activator PF-04937319 and its disproportionate N-demethylated metabolite using humanized chimeric mice and semi-physiological pharmacokinetic modeling. Xenobiotica 47:382–93.
  • Kannan R, Miller S, Singh BN. (1985). Tissue uptake and metabolism of amiodarone after chronic administration in rabbits. Drug Metab Dispos 13:646–50.
  • Karbwang J, White NJ. (1990). Clinical pharmacokinetics of mefloquine. Clin Pharmacokinet 19:264–79.
  • 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.
  • Kim KP, Kim BH, Lim KS, et al. (2009). Potential interactions between cilostazol and probucol: a two-part, single-dose, open-label study in healthy Korean male volunteers. Clin Ther 31:2098–106.
  • Kivisto KT, Villikka K, Nyman L, et al. (1998). Tamoxifen and toremifene concentrations in plasma are greatly decreased by rifampin. Clin Pharmacol Ther 64:648–54.
  • Klein DJ, Thorn CF, Desta Z, et al. (2013). PharmGKB summary: tamoxifen pathway, pharmacokinetics. Pharmacogenet Genomics 23:643–7.
  • Kolawole JA, Mustapha A, Abudu-Aguye I, et al. (2000). Mefloquine pharmacokinetics in healthy subjects and in peptic ulcer patients after cimetidine administration. Eur J Drug Metab Pharmacokinet 25:165–70.
  • Kubo M, Koue T, Inaba A, et al. (2005). Influence of itraconazole co-administration and CYP2D6 genotype on the pharmacokinetics of the new antipsychotic ARIPIPRAZOLE. Drug Metab Pharmacokinet 20:55–64.
  • Latini R, Tognoni G, Kates RE. (1984). Clinical pharmacokinetics of amiodarone. Clin Pharmacokinet 9:136–56.
  • Lombardo F, Berellini G, Labonte LR, et al. (2016). Systematic evaluation of Wajima superposition (steady-state concentration to mean residence time) in the estimation of human intravenous pharmacokinetic profile. J Pharm Sci 105:1277–87.
  • Lombardo F, Waters NJ, Argikar UA, et al. (2013). 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. (2013). 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.
  • Miyamoto M, Iwasaki S, Chisaki I, et al. (2017). Comparison of predictability for human pharmacokinetics parameters among monkeys, rats, and chimeric mice with humanised liver. Xenobiotica 47:1052–63.
  • Nakayama K, Ito S, Suzuki M, et al. (2018). Prediction of human pharmacokinetics of typical compounds by a physiologically based method using chimeric mice with humanized liver. Xenobiotica 1–11. doi: 10.1080/00498254.2018.1460516
  • Patel IH, Levy RH, Cutler RE. (1980). Phenobarbital-valporic acid interaction. Clin Pharmacol Ther 27:515–21.
  • Plomp TA, van Rossum JM, Robles de Medina EO, et al. (1984). Pharmacokinetics and body distribution of amiodarone in man. Arzneimittelforschung 34:513–20.
  • Sanoh S, Horiguchi A, Sugihara K, et al. (2012). 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.
  • Sarver JG, White D, Erhardt P, et al. (1997). Estimating xenobiotic half-lives in humans from rat data: influence of log P. Environ Health Perspect 105:1204–9.
  • Smith DA, Beaumont K, Maurer TS, et al. (2017). Relevance of half-life in drug design. J Med Chem 61:4273–4282.
  • 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.
  • U.S. Food and Drug Administration: FDA approval package document: Clinical Pharmacology and Biopharmaceutics Review, Application number: 020377.
  • U.S. Food and Drug Administration: FDA approval package document: Clinical Pharmacology and Biopharmaceutics Review, Application number: 021866.
  • Vuppugalla R, Marathe P, He H, et al. (2011). PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 4: prediction of plasma concentration-time profiles in human from in vivo preclinical data by using the Wajima approach. J Pharm Sci 100:4111–26.
  • Wajima T, Yano Y, Fukumura K, et al. (2004). Prediction of human pharmacokinetic profile in animal scale up based on normalizing time course profiles. J Pharm Sci 93:1890–900.
  • Zhi J, Moore R, Kanitra L, et al. (2003). Effects of orlistat, a lipase inhibitor, on the pharmacokinetics of three highly lipophilic drugs (amiodarone, fluoxetine, and simvastatin) in healthy volunteers. J Clin Pharmacol 43:428–35.

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.