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Volumn 102, Issue 11, 2013, Pages 4193-4204

Development of a hybrid physiologically based pharmacokinetic model with drug-specific scaling factors in rat to improve prediction of human pharmacokinetics

Author keywords

ADME; in vitro in vivo extrapolation (IVIVE); Metabolic clearance; Modeling and simulation; PBPK modeling; Pharmacokinetics; Physiological model; Prediction of human pharmacokinetics; Simulations; Translational research

Indexed keywords

CAFFEINE; DIAZEPAM; DILTIAZEM; EPIROPRIM; MIDAZOLAM; NICARDIPINE; PHENAZONE; PROPAFENONE; THEOPHYLLINE; VERAPAMIL;

EID: 84885864833     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23726     Document Type: Article
Times cited : (13)

References (28)
  • 2
    • 0036075799 scopus 로고    scopus 로고
    • Prediction of pharmacokinetics prior to in vivo studies. II. Generic physiologically based pharmacokinetic models of drug disposition
    • Poulin P, Theil FP. 2002. Prediction of pharmacokinetics prior to in vivo studies. II. Generic physiologically based pharmacokinetic models of drug disposition. J Pharm Sci 91:1358-1370.
    • (2002) J Pharm Sci , vol.91 , pp. 1358-1370
    • Poulin, P.1    Theil, F.P.2
  • 3
    • 40549113994 scopus 로고    scopus 로고
    • Evaluation of a generic physiologically based pharmacokinetic model for lineshape analysis
    • Peters SA. 2008. Evaluation of a generic physiologically based pharmacokinetic model for lineshape analysis. Clin Pharmacokinet 47:261-275.
    • (2008) Clin Pharmacokinet , vol.47 , pp. 261-275
    • Peters, S.A.1
  • 5
    • 0014763674 scopus 로고
    • Interspecies correlation of plasma concentration history of methotrexate (NSC-740)
    • Dedrick R, Bischoff KB, Zaharko DS. 1970. Interspecies correlation of plasma concentration history of methotrexate (NSC-740). Cancer Chemother Rep 54:95-101.
    • (1970) Cancer Chemother Rep , vol.54 , pp. 95-101
    • Dedrick, R.1    Bischoff, K.B.2    Zaharko, D.S.3
  • 6
    • 0028828607 scopus 로고
    • Interspecies scaling of interferon disposition and comparison of allometric scaling with concentration-time transformations
    • Lave T, Levet-Trafit B, Schmitt-Hoffmann AH, Morgenroth B, Richter W, Chou RC. 1995. Interspecies scaling of interferon disposition and comparison of allometric scaling with concentration-time transformations. J Pharm Sci 84:1285-1290.
    • (1995) J Pharm Sci , vol.84 , pp. 1285-1290
    • Lave, T.1    Levet-Trafit, B.2    Schmitt-Hoffmann, A.H.3    Morgenroth, B.4    Richter, W.5    Chou, R.C.6
  • 7
    • 79960176175 scopus 로고    scopus 로고
    • Prediction of human oral plasma concentration-time profiles using preclinical data: Comparative evaluation of prediction approaches in early pharmaceutical discovery
    • Van den Bergh A, Sinha V, Gilissen R, Straetemans R, Wuyts K, Morrison D, Bijnens L, Mackie C. 2011. Prediction of human oral plasma concentration-time profiles using preclinical data: Comparative evaluation of prediction approaches in early pharmaceutical discovery. Clin Pharmacokinet 50:505-517.
    • (2011) Clin Pharmacokinet , vol.50 , pp. 505-517
    • Van den Bergh, A.1    Sinha, V.2    Gilissen, R.3    Straetemans, R.4    Wuyts, K.5    Morrison, D.6    Bijnens, L.7    Mackie, C.8
  • 8
    • 0030918716 scopus 로고    scopus 로고
    • Integration of in vitro data into allometric scaling to predict hepatic metabolic clearance in man: Application to 10 extensively metabolized drugs
    • Lave T, Dupin S, Schmitt C, Chou RC, Jaeck D, Coassolo P. 1997. Integration of in vitro data into allometric scaling to predict hepatic metabolic clearance in man: Application to 10 extensively metabolized drugs. J Pharm Sci 86:584-590.
    • (1997) J Pharm Sci , vol.86 , pp. 584-590
    • Lave, T.1    Dupin, S.2    Schmitt, C.3    Chou, R.C.4    Jaeck, D.5    Coassolo, P.6
  • 9
    • 33344457255 scopus 로고    scopus 로고
    • A global examination of allometric scaling for predicting human drug clearance and the prediction of large vertical allometry
    • Tang H, Mayersohn M. 2006. A global examination of allometric scaling for predicting human drug clearance and the prediction of large vertical allometry. J Pharm Sci 95:1783-1799.
    • (2006) J Pharm Sci , vol.95 , pp. 1783-1799
    • Tang, H.1    Mayersohn, M.2
  • 10
    • 84872689874 scopus 로고    scopus 로고
    • Application of hybrid approach based on empirical and physiological concept for predicting pharmacokinetics in humans-usefulness of exponent on prospective evaluation of predictability
    • Sayama H, Komura H, Kogayu M. 2013. Application of hybrid approach based on empirical and physiological concept for predicting pharmacokinetics in humans-usefulness of exponent on prospective evaluation of predictability. Drug Metab Dispos 41:498-507.
    • (2013) Drug Metab Dispos , vol.41 , pp. 498-507
    • Sayama, H.1    Komura, H.2    Kogayu, M.3
  • 11
    • 17644381224 scopus 로고    scopus 로고
    • Prediction of human drug clearance from in vitro and preclinical data using physiologically based and empirical approaches
    • Ito K, Houston JB. 2005. Prediction of human drug clearance from in vitro and preclinical data using physiologically based and empirical approaches. Pharm Res 22:103-112.
    • (2005) Pharm Res , vol.22 , pp. 103-112
    • Ito, K.1    Houston, J.B.2
  • 12
    • 77957344287 scopus 로고    scopus 로고
    • Prediction of human metabolic clearance from in vitro systems: Retrospective analysis and prospective view
    • 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.
    • (2010) Pharm Res , vol.27 , pp. 2150-2161
    • Hallifax, D.1    Foster, J.A.2    Houston, J.B.3
  • 13
    • 0034835463 scopus 로고    scopus 로고
    • Prediction of human hepatic clearance from in vivo animal experiments and in vitro metabolic studies with liver microsomes from animals and humans
    • Naritomi Y, Terashita S, Kimura S, Suzuki A, Kagayama A, Sugiyama Y. 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 29:1316-1324.
    • (2001) Drug Metab Dispos , vol.29 , pp. 1316-1324
    • Naritomi, Y.1    Terashita, S.2    Kimura, S.3    Suzuki, A.4    Kagayama, A.5    Sugiyama, Y.6
  • 14
    • 33646124969 scopus 로고    scopus 로고
    • A novel strategy for physiologically based predictions of human pharmacokinetics
    • Jones HM, Parrott N, Jorga K, Lavé T. 2006. A novel strategy for physiologically based predictions of human pharmacokinetics. Clin Pharmacokinet 45:511-542.
    • (2006) Clin Pharmacokinet , vol.45 , pp. 511-542
    • Jones, H.M.1    Parrott, N.2    Jorga, K.3    Lavé, T.4
  • 15
    • 0036891948 scopus 로고    scopus 로고
    • The influence of nonspecific microsomal binding on apparent intrinsic clearance, and its prediction from physicochemical properties
    • Austin RP, Barton P, Cockroft SL, Wenlock MC, Riley RJ. 2002. The influence of nonspecific microsomal binding on apparent intrinsic clearance, and its prediction from physicochemical properties. Drug Metab Dispos 30:1497-1503.
    • (2002) Drug Metab Dispos , vol.30 , pp. 1497-1503
    • Austin, R.P.1    Barton, P.2    Cockroft, S.L.3    Wenlock, M.C.4    Riley, R.J.5
  • 16
    • 14044251501 scopus 로고    scopus 로고
    • The binding of drugs to hepatocytes and its relationship to physicochemical properties
    • Austin RP, Barton P, Mohmed S, Riley RJ. 2005. The binding of drugs to hepatocytes and its relationship to physicochemical properties. Drug Metab Dispos 33:419-425.
    • (2005) Drug Metab Dispos , vol.33 , pp. 419-425
    • Austin, R.P.1    Barton, P.2    Mohmed, S.3    Riley, R.J.4
  • 17
    • 0033966128 scopus 로고    scopus 로고
    • A priori prediction of tissue: Plasma partition coefficients of drugs to facilitate the use of physiologically-based pharmacokinetic models in drug discovery
    • Poulin P, Theil FP. 2000. A priori prediction of tissue: Plasma partition coefficients of drugs to facilitate the use of physiologically-based pharmacokinetic models in drug discovery. J Pharm Sci 89:16-35.
    • (2000) J Pharm Sci , vol.89 , pp. 16-35
    • Poulin, P.1    Theil, F.P.2
  • 18
    • 21344469211 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic modeling 1: Predicting the tissue distribution of moderate-to-strong bases
    • Rodgers T, Leahy D, Rowland M. 2005. Physiologically based pharmacokinetic modeling 1: Predicting the tissue distribution of moderate-to-strong bases. J Pharm Sci 94:1259-1276.
    • (2005) J Pharm Sci , vol.94 , pp. 1259-1276
    • Rodgers, T.1    Leahy, D.2    Rowland, M.3
  • 19
    • 33745055239 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic modelling 2: Predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions
    • Rodgers T, Rowland M. 2006. Physiologically based pharmacokinetic modelling 2: Predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions. J Pharm Sci 95:1238-1257.
    • (2006) J Pharm Sci , vol.95 , pp. 1238-1257
    • Rodgers, T.1    Rowland, M.2
  • 20
    • 34047157087 scopus 로고    scopus 로고
    • The prediction of drug metabolism, tissue distribution, and bioavailability of 50 structurally diverse compounds in rat using mechanism-based absorption, distribution, and metabolism prediction tools
    • De Buck SS, Sinha VK, Fenu LA, Gilissen RA, Mackie CE, Nijsen MJ. 2007. The prediction of drug metabolism, tissue distribution, and bioavailability of 50 structurally diverse compounds in rat using mechanism-based absorption, distribution, and metabolism prediction tools. Drug Metab Dispos 35:649-659.
    • (2007) Drug Metab Dispos , vol.35 , pp. 649-659
    • Buck, S.S.1    Sinha, V.K.2    Fenu, L.A.3    Gilissen, R.A.4    Mackie, C.E.5    Nijsen, M.J.6
  • 21
    • 0037403950 scopus 로고    scopus 로고
    • Utility of hepatocytes in predicting drug metabolism: Comparison of hepatic intrinsic clearance in rats and humans in vivo and in vitro
    • Naritomi Y, Terashita S, Kagayama A, Sugiyama Y. 2003. Utility of hepatocytes in predicting drug metabolism: Comparison of hepatic intrinsic clearance in rats and humans in vivo and in vitro. Drug Metab Dispos 31:580-588.
    • (2003) Drug Metab Dispos , vol.31 , pp. 580-588
    • Naritomi, Y.1    Terashita, S.2    Kagayama, A.3    Sugiyama, Y.4
  • 22
    • 40849096159 scopus 로고    scopus 로고
    • Drug lipophilicity and microsomal protein concentration as determinants in the prediction of the fraction unbound in microsomal incubations
    • Gertz M, Kilford PJ, Houston JB, Galetin A. 2008. Drug lipophilicity and microsomal protein concentration as determinants in the prediction of the fraction unbound in microsomal incubations. Drug Metab Dispos 36:535-542.
    • (2008) Drug Metab Dispos , vol.36 , pp. 535-542
    • Gertz, M.1    Kilford, P.J.2    Houston, J.B.3    Galetin, A.4
  • 23
    • 34548393250 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetics-evaluation of methods for prediction of volume of distribution
    • Fagerholm U. 2007. Prediction of human pharmacokinetics-evaluation of methods for prediction of volume of distribution. J Pharm Pharmacol 59:1181-1190.
    • (2007) J Pharm Pharmacol , vol.59 , pp. 1181-1190
    • Fagerholm, U.1
  • 24
    • 34748925493 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetics using physiologically based modeling: A retrospective analysis of 26 clinically tested drugs
    • De Buck SS, Sinha VK, Fenu LA, Nijsen MJ, Mackie CE, Gilissen RA. 2007b. Prediction of human pharmacokinetics using physiologically based modeling: A retrospective analysis of 26 clinically tested drugs. Drug Metab Dispos 35:1766-1780.
    • (2007) Drug Metab Dispos , vol.35 , pp. 1766-1780
    • Buck, S.S.D.1    Sinha, V.K.2    Fenu, L.A.3    Nijsen, M.J.4    Mackie, C.E.5    Gilissen, R.A.6
  • 26
    • 47749125276 scopus 로고    scopus 로고
    • Prediction of drug tissue to plasma concentration ratios using a measured volume of distribution in combination with lipophilicity
    • Jansson R, Bredberg U, Ashton M. 2008. Prediction of drug tissue to plasma concentration ratios using a measured volume of distribution in combination with lipophilicity. J Pharm Sci 97:2324-2339.
    • (2008) J Pharm Sci , vol.97 , pp. 2324-2339
    • Jansson, R.1    Bredberg, U.2    Ashton, M.3
  • 27
    • 79951888374 scopus 로고    scopus 로고
    • Prediction of oral pharmacokinetics of cMet kinase inhibitors in humans: Physiologically based pharmacokinetic model versus traditional one-compartment model
    • Yamazaki S, Skaptason J, Romero D, Vekich S, Jones HM, Tan W, Wilner KD, Koudriakova T. 2011. Prediction of oral pharmacokinetics of cMet kinase inhibitors in humans: Physiologically based pharmacokinetic model versus traditional one-compartment model. Drug Metab Dispos 39:383-393.
    • (2011) Drug Metab Dispos , vol.39 , pp. 383-393
    • Yamazaki, S.1    Skaptason, J.2    Romero, D.3    Vekich, S.4    Jones, H.M.5    Tan, W.6    Wilner, K.D.7    Koudriakova, T.8
  • 28
    • 84862619047 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: A marriage under the arch of systems pharmacology
    • Rostami-Hodjegan A. 2012. Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: A marriage under the arch of systems pharmacology. Clin Pharmacol Ther 92:50-61.
    • (2012) Clin Pharmacol Ther , vol.92 , pp. 50-61
    • Rostami-Hodjegan, A.1


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