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Xenobiotica
the fate of foreign compounds in biological systems
Volume 51, 2021 - Issue 1
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General Xenobiochemistry

Characterization of plasma protein binding in two mouse models of humanized liver, PXB mouse and humanized TK-NOG mouse

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Pages 51-60 | Received 09 Jun 2020, Accepted 07 Aug 2020, Published online: 25 Aug 2020

References

  • Aarons L, Grennan DM, Siddiqui M. (1983). The binding of ibuprofen to plasma proteins. Eur J Clin Pharmacol 25:815–8.
  • 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.
  • Benet LZ, Hoener BA. (2002). Changes in plasma protein binding have little clinical relevance. Clin Pharmacol Ther 71:115–21.
  • Bogdan M, Pirnau A, Floare C, Bugeac C. (2008). Binding interaction of indomethacin with human serum albumin. J Pharm Biomed Anal 47:981–4.
  • Brammer KW, Farrow PR, Faulkner JK. (1990). Pharmacokinetics and tissue penetration of fluconazole in humans. Rev Infect Dis 12:S318–S26.
  • Chan KK, Vyas KH, Brandt KD. (1987). In vitro protein binding of diclofenac sodium in plasma and synovial fluid. J Pharm Sci 76:105–8.
  • Day RO, Francis H, Vial J, et al. (1995). Naproxen concentrations in plasma and synovial fluid and effects on prostanoid concentrations. J Rheumatol 22:2295–303.
  • Debruyne D. (1997). Clinical pharmacokinetics of fluconazole in superficial and systemic mycoses. Clin Pharmacokinet 33:52–77.
  • DI L, Breen C, Chambers R, et al. (2017). Industry perspective on contemporary protein-binding methodologies: considerations for regulatory drug-drug interaction and related guidelines on highly bound drugs. J Pharm Sci 106:3442–52.
  • EMA. 2012. EMA guidelines on the investigation of drug interactions.
  • FDA. 2012. FDA Guidance for industry. Drug interaction studies – Study design, data analysis, implications for dosing, and labeling recommendations.
  • Fuse E, Kuwabara T, Sparreboom A, et al. (2005). Review of UCN-01 development: a lesson in the importance of clinical pharmacology. J Clin Pharmacol 45:394–403.
  • Hammarlund-Udenaes M, Fridén M, Syvänen S, Gupta A. (2008). On the rate and extent of drug delivery to the brain. Pharm Res 25:1737–50.
  • Hanke N, Frechen S, Moj D, et al. (2018). PBPK models for CYP3A4 and P-gp DDI prediction: a modeling network of rifampicin, itraconazole, clarithromycin, midazolam, alfentanil, and digoxin. CPT Pharmacometrics Syst Pharmacol 7:647–59.
  • Hasegawa M, Kawai K, Mitsui T, et al. (2011). The reconstituted 'humanized liver' in TK-NOG mice is mature and functional. Biochem Biophys Res Commun 405:405–10.
  • Hasegawa M, Tahara H, Inoue R, et al. (2012). Investigation of drug-drug interactions caused by human pregnane X receptor-mediated induction of CYP3A4 and CYP2C subfamilies in chimeric mice with a humanized liver. Drug Metab Dispos 40:474–80.
  • Heuberger J, Schmidt S, Derendorf H. (2013). When is protein binding important?. J Pharm Sci 102:3458–67.
  • Hochman J, Tang C, Prueksaritanont T. (2015). Drug-drug interactions related to altered absorption and plasma protein binding: theoretical and regulatory considerations, and an industry perspective. J Pharm Sci 104:916–29.
  • 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.
  • Honda GS, Pearce RG, Pham LL, et al. (2019). Using the concordance of in vitro and in vivo data to evaluate extrapolation assumptions. PLoS One 14:e0217564.
  • 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.
  • Kakuni M, Morita M, Matsuo K, et al. (2012). Chimeric mice with a humanized liver as an animal model of troglitazone-induced liver injury. Toxicol Lett 214:9–18.
  • Kalvass J C, Phipps C, Jenkins G J, et al. (2018). Mathematical and experimental validation of Flux Dialysis Method: an improved approach to measure unbound fraction for compounds with high protein binding and other challenging properties. Drug Metab Dispos 46:458–69.
  • Kamimura H, Ito S, Nozawa K, et al. (2015). Formation of the accumulative human metabolite and human-specific glutathione conjugate of diclofenac in TK-NOG chimeric mice with humanized livers. Drug Metab Dispos 43:309–16.
  • 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, Nakajima M, et al. (2005a). In vivo induction of human cytochrome P450 enzymes expressed in chimeric mice with humanized liver. Drug Metab Dispos 33:754–63.
  • Katoh M, Matsui T, Okumura H, et al. (2005b). Expression of human phase II enzymes in chimeric mice with humanized liver. Drug Metab Dispos 33:1333–40.
  • Klumpp K, Shimada T, Allweiss L, et al. (2018). Efficacy of NVR 3-778, alone and in combination with pegylated interferon, vs entecavir in uPA/SCID mice with humanized livers and HBV infection. Gastroenterology 154:652–62e8.
  • Lammers I, Lhiaubet-Vallet V, Ariese F, et al. (2013). Binding of naproxen enantiomers to human serum albumin studied by fluorescence and room-temperature phosphorescence. Spectrochim Acta A Mol Biomol Spectrosc 105:67–73.
  • Li F, Zhou D, Guo X. (2003). Study on the protein binding of ketoprofen using capillary electrophoresis frontal analysis compared with liquid chromatography frontal analysis. J Chromatogr Sci 41:137–41.
  • Lin JH. (2008). CSF as a surrogate for assessing CNS exposure: an industrial perspective. Curr Drug Metab 9:46–59.
  • Liu X, Smith BJ, Chen C, et al. (2006). Evaluation of cerebrospinal fluid concentration and plasma free concentration as a surrogate measurement for brain free concentration. Drug Metab Dispos 34:1443–7.
  • 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.
  • Maurer TS, Debartolo DB, Tess DA, Scott DO. (2005). Relationship between exposure and nonspecific binding of thirty-three central nervous system drugs in mice. Drug Metab Dispos 33:175–81.
  • 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.
  • Miyamoto M, Iwasaki S, Chisaki I, et al. (2019). Prediction of human pharmacokinetics of long half-life compounds using chimeric mice with humanised liver. Xenobiotica 49:1379–87.
  • Mueller H, Wildum S, Luangsay S, et al. (2018). A novel orally available small molecule that inhibits hepatitis B virus expression. J Hepatol 68:412–20.
  • Nakayama K, Ito S, Suzuki M, et al. (2019). Prediction of human pharmacokinetics of typical compounds by a physiologically based method using chimeric mice with humanized liver. Xenobiotica 49:404–14.
  • Nakayama K, Kamimura H, Suemizu H, et al. (2020). Predicted values for human total clearance of a variety of typical compounds with differently humanized-liver mouse plasma data. Drug Metabol Pharmacokinet 35:389–96.
  • Naritomi Y, Sanoh S, Ohta S. (2018). Chimeric mice with humanized liver: Application in drug metabolism and pharmacokinetics studies for drug discovery. Drug Metab Pharmacokinet 33:31–9.
  • Naritomi Y, Sanoh S, Ohta S. (2019). Utility of chimeric mice with humanized liver for predicting human pharmacokinetics in drug discovery: comparison with in vitro-in vivo extrapolation and allometric scaling. Biol Pharm Bull 42:327–36.
  • Nihira K, Nan-Ya KI, Kakuni M, et al. (2019). Chimeric mice with humanized livers demonstrate human-specific hepatotoxicity caused by a therapeutic antibody against TRAIL-receptor 2/death receptor 5. Toxicol Sci 167:190–201.
  • Nishiyama S, Suemizu H, Shibata N, et al. (2015). Simulation of human plasma concentrations of thalidomide and primary 5-hydroxylated metabolites explored with pharmacokinetic data in humanized TK-NOG mice. Chem Res Toxicol 28:2088–90.
  • Papazyan R, Liu X, Liu J, et al. (2018). FXR activation by obeticholic acid or nonsteroidal agonists induces a human-like lipoprotein cholesterol change in mice with humanized chimeric liver. J Lipid Res 59:982–93.
  • Paterson SC, Lim CK, Smith KD. (2003). Analysis of the interaction between alpha-1-acid glycoprotein and tamoxifen and its metabolites. Biomed Chromatogr 17:143–8.
  • Piafsky KM, Borga O. (1977). Plasma protein binding of basic drugs. II. Importance of alpha 1-acid glycoprotein for interindividual variation. Clin Pharmacol Ther 22:545–9.
  • Redfern WS, Carlsson L, Davis AS, et al. (2003). Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development. Cardiovasc Res 58:32–45.
  • Sakurama K, Kawai A, Tuan Giam Chuang V, et al. (2018). Analysis of the binding of aripiprazole to human serum albumin: the importance of a chloro-group in the chemical structure. ACS Omega 3:13790–7.
  • 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. (2012). 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, Tamura Y, Fujino C, et al. (2019). Changes in bile acid concentrations after administration of ketoconazole or rifampicin to chimeric mice with humanized liver. Biol Pharm Bull 42:1366–75.
  • Sanoh S, Yamachika Y, Tamura Y, et al. (2017). Assessment of amiodarone-induced phospholipidosis in chimeric mice with a humanized liver. J Toxicol Sci 42:589–96.
  • 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.
  • Schramm P, Wildfeuer A, Sarnow E. (1994). Determination of fluconazole concentrations in the prostatic and seminal vesicle fluid (split ejaculate). Mycoses 37:417–20.
  • Shoda J, Okada K, Inada Y, et al. (2007). Bezafibrate induces multidrug-resistance P-Glycoprotein 3 expression in cultured human hepatocytes and humanized livers of chimeric mice. Hepatol Res 37:548–56.
  • Smith DA, DI L, Kerns EH. (2010). The effect of plasma protein binding on in vivo efficacy: misconceptions in drug discovery. Nat Rev Drug Discov 9:929–39.
  • Smith SA, Waters NJ. (2018). Pharmacokinetic and pharmacodynamic considerations for drugs binding to alpha-1-acid glycoprotein. Pharm Res 36:30.
  • Soars MG, Burchell B, Riley RJ. (2002). In vitro analysis of human drug glucuronidation and prediction of in vivo metabolic clearance. J Pharmacol Exp Ther 301:382–90.
  • Stangier J, Schmid J, Turck D, et al. (2000). Absorption, metabolism, and excretion of intravenously and orally administered [14C]telmisartan in healthy volunteers. J Clin Pharmacol 40:1312–22.
  • Suzuki E, Koyama K, Nakai D, et al. (2017). Observation of clinically relevant drug interaction in chimeric mice with humanized livers: the case of valproic acid and carbapenem antibiotics. Eur J Drug Metab Pharmacokinet 42:965–72.
  • Takaoka N, Sanoh S, Okuda K, et al. (2018). Inhibitory effects of drugs on the metabolic activity of mouse and human aldehyde oxidases and influence on drug-drug interactions. Biochem Pharmacol 154:28–38.
  • Takehara I, Watanabe N, Mori D, et al. (2019). Effect of rifampicin on the plasma concentrations of bile acid-O-sulfates in monkeys and human liver-transplanted chimeric mice with or without bile flow diversion. J Pharm Sci 108:2756–64.
  • Tateno C, Fukumuro M, Masumori S, et al. (2019). Chimeric mice with human hepatocytes: a new system for genotoxicity studies. Mutat Res Genet Toxicol Environ Mutagen 839:9–12.
  • Tateno C, Miya F, Wake K, et al. (2013). Morphological and microarray analyses of human hepatocytes from xenogeneic host livers. Lab Invest 93:54–71.
  • Tateno C, Yamamoto T, Utoh R, et al. (2015). Chimeric mice with hepatocyte-humanized liver as an appropriate model to study human peroxisome proliferator-activated receptor-α. Toxicol Pathol 43:233–48.
  • 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.
  • Trainor GL. (2007). The importance of plasma protein binding in drug discovery. Expert Opin Drug Discov 2:51–64.
  • Uchida T, Hiraga N, Imamura M, et al. (2015). Human cytotoxic T lymphocyte-mediated acute liver failure and rescue by immunoglobulin in human hepatocyte transplant TK-NOG Mice. J Virol 89:10087–96.
  • Uchida T, Imamura M, Kan H, et al. (2017). Usefulness of humanized cDNA-uPA/SCID mice for the study of hepatitis B virus and hepatitis C virus virology. J Gen Virol 98:1040–7.
  • Uchida M, Tajima Y, Kakuni M, et al. (2018). Organic anion-transporting polypeptide (OATP)-mediated drug-drug interaction study between rosuvastatin and cyclosporine A in chimeric mice with humanized liver. Drug Metab Dispos 46:11–9.
  • 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.
  • Webster R, Leishman D, Walker D. (2002). Towards a drug concentration effect relationship for QT prolongation and torsades de pointes. Curr Opin Drug Discov Devel 5:116–26.
  • Xu D, Michie SA, Zheng M, et al. (2015a). Humanized thymidine kinase-NOG mice can be used to identify drugs that cause animal-specific hepatotoxicity: a case study with furosemide. J Pharmacol Exp Ther 354:73–8.
  • Xu D, Wu M, Nishimura S, et al. (2015b). Chimeric TK-NOG mice: a predictive model for cholestatic human liver toxicity. J Pharmacol Exp Ther 352:274–80.
  • Yamazaki H, Suemizu H, Murayama N, et al. (2013). In vivo drug interactions of the teratogen thalidomide with midazolam: heterotropic cooperativity of human cytochrome P450 in humanized TK-NOG mice. Chem Res Toxicol 26:486–9.
  • Yamazaki H, Suemizu H, Shimizu M, et al. (2012). In vivo formation of dihydroxylated and glutathione conjugate metabolites derived from thalidomide and 5-Hydroxythalidomide in humanized TK-NOG mice. Chem Res Toxicol 25:274–6.
  • Yoshizato K, Tateno C. (2013). A mouse with humanized liver as an animal model for predicting drug effects and for studying hepatic viral infection: where to next?. Expert Opin Drug Metab Toxicol 9:1419–35.

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