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Volumn 100, Issue 10, 2011, Pages 4127-4157

PHRMA CPCDC initiative on predictive models of human pharmacokinetics, part 5: Prediction of plasma concentration-time profiles in human by using the physiologically-based pharmacokinetic modeling approach

(18)  Poulin, Patrick a   Jones, Rhys D O b   Jones, Hannah M c   Gibson, Christopher R d   Rowland, Malcolm e   Chien, Jenny Y f   Ring, Barbara J f   Adkison, Kimberly K g   Ku, M Sherry h   He, Handan i   Vuppugalla, Ragini j   Marathe, Punit j   Fischer, Volker k   Dutta, Sandeep k   Sinha, Vikash K l   Björnsson, Thorir m   Lavé, Thierry n   Yates, James W T b  


Author keywords

Absorption; Animal alternative; Computational ADME; Disposition; Distribution; Drug development; Drug discovery; In vitro in vivo correlation; PBPK modeling; Pharmacokinetics

Indexed keywords

ADIPOSE DERIVED STEM CELL; AREA UNDER THE CURVE; ARTERIAL BLOOD; ARTICLE; BONE; BRAIN; DRUG CLEARANCE; DRUG DIFFUSION; DRUG SOLUBILITY; HEART; HEPATIC ARTERY; HUMAN; HUMAN TISSUE; KIDNEY; LIPOPHILICITY; LIVER; LUNG PARENCHYMA; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PHYSICAL CHEMISTRY; PLASMA CONCENTRATION-TIME CURVE; PREDICTION; PREDICTIVE VALUE; SIMULATION; SKIN CULTURE; SPLEEN; TIME TO MAXIMUM PLASMA CONCENTRATION; VENOUS BLOOD; ACCESS TO INFORMATION; ANIMAL; BIOLOGICAL MODEL; BLOOD; COMPUTER SIMULATION; COOPERATION; DRUG DATABASE; DRUG DEVELOPMENT; DRUG SCREENING; EVALUATION STUDY; GASTROINTESTINAL ABSORPTION; INTERDISCIPLINARY COMMUNICATION; INTRAVENOUS DRUG ADMINISTRATION; METABOLIC CLEARANCE RATE; METABOLISM; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; PROCEDURES; PROGRAM DEVELOPMENT; PROGRAM EVALUATION; REPRODUCIBILITY; SPECIES DIFFERENCE; STATISTICAL MODEL;

EID: 80052262709     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22550     Document Type: Article
Times cited : (155)

References (50)
  • 6
    • 0014763674 scopus 로고
    • Interspecies correlation of plasma concentration history of methotrexate
    • Dedrick R, Bischoff KB, Zaharko DS. 1970. Interspecies correlation of plasma concentration history of methotrexate. 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
  • 7
    • 3042648079 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetic profile in animal scale up based on normalizing time course profiles
    • Wajima T, Yano Y, Fukumura K, Oguma T. 2004. Prediction of human pharmacokinetic profile in animal scale up based on normalizing time course profiles. J Pharm Sci 93:1890-1900.
    • (2004) J Pharm Sci , vol.93 , pp. 1890-1900
    • Wajima, T.1    Yano, Y.2    Fukumura, K.3    Oguma, T.4
  • 9
    • 0037452445 scopus 로고    scopus 로고
    • Utility of physiologically-based pharmacokinetic (PBPK) model to drug development and rational drug discovery candidate selection
    • Theil FP, Guentert TW, Haddad S, Poulin P. 2003. Utility of physiologically-based pharmacokinetic (PBPK) model to drug development and rational drug discovery candidate selection. Tox Lett 138:29-49.
    • (2003) Tox Lett , vol.138 , pp. 29-49
    • Theil, F.P.1    Guentert, T.W.2    Haddad, S.3    Poulin, P.4
  • 10
    • 0035478779 scopus 로고    scopus 로고
    • Predicting the impact of physiological and biochemical processes on oral drug bioavailability
    • SUPPL
    • Agoram B, Woltosz WS, Bolger MB. 2001. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv Drug Deliv Rev 50 Suppl 1:S41-67.
    • (2001) Adv Drug Deliv Rev , vol.50 , Issue.1
    • Agoram, B.1    Woltosz, W.S.2    Bolger, M.B.3
  • 12
    • 33646124969 scopus 로고    scopus 로고
    • A novel strategy for physiologically based predictions of human pharmacokinetics
    • Jones HM, Parrott N, Jorga K, Lave T. 2006. A novel strategy for physiologically based predictions of human pharmacokinetics. Clin Pharmacokinet 45(5):511-542.
    • (2006) Clin Pharmacokinet , vol.45 , Issue.5 , pp. 511-542
    • Jones, H.M.1    Parrott, N.2    Jorga, K.3    Lave, T.4
  • 13
    • 65549096369 scopus 로고    scopus 로고
    • Modeling and PBPK simulation in drug discovery
    • Jones HM, Gardner IB, Watson KJ. 2009. Modeling and PBPK simulation in drug discovery. AAPS J 11:155-166.
    • (2009) AAPS J , vol.11 , pp. 155-166
    • Jones, H.M.1    Gardner, I.B.2    Watson, K.J.3
  • 15
    • 35648955151 scopus 로고    scopus 로고
    • Challenges and opportunities with modeling and simulation in drug discovery and drug development
    • Lavé T, Parrott N, Grimm HP, Fleury A, Reddy M. 2007. Challenges and opportunities with modeling and simulation in drug discovery and drug development. Xenobiotica 37:1295-1310.
    • (2007) Xenobiotica , vol.37 , pp. 1295-1310
    • Lavé, T.1    Parrott, N.2    Grimm, H.P.3    Fleury, A.4    Reddy, M.5
  • 16
    • 35648945837 scopus 로고    scopus 로고
    • On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development
    • Lowe PJ, Hijazi Y, Luttringer O, Yin H, Sarangapani R, Howard D. 2007. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development. Xenobiotica 37:1331-1354.
    • (2007) Xenobiotica , vol.37 , pp. 1331-1354
    • Lowe, P.J.1    Hijazi, Y.2    Luttringer, O.3    Yin, H.4    Sarangapani, R.5    Howard, D.6
  • 17
    • 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. 2007. 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
    • De Buck, S.S.1    Sinha, V.K.2    Fenu, L.A.3    Nijsen, M.J.4    Mackie, C.E.5    Gilissen, R.A.6
  • 18
    • 43349093221 scopus 로고    scopus 로고
    • Projection of exposure and efficacious dose prior to first-in-human studies: How successful have we been?
    • Huang C, Zheng M, Yang Z, Rodrigues AD, Marathe P. 2008. Projection of exposure and efficacious dose prior to first-in-human studies: How successful have we been? Pharm Res 25:713-726.
    • (2008) Pharm Res , vol.25 , pp. 713-726
    • Huang, C.1    Zheng, M.2    Yang, Z.3    Rodrigues, A.D.4    Marathe, P.5
  • 19
    • 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
  • 20
    • 63149182785 scopus 로고    scopus 로고
    • Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: Strategic considerations
    • Gabrielsson J, Dolgos H, Gillberg PG, Bredberg U, Benthem B, Duker G. 2009. Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: Strategic considerations. Drug Discov Today 14:358-372.
    • (2009) Drug Discov Today , vol.14 , pp. 358-372
    • Gabrielsson, J.1    Dolgos, H.2    Gillberg, P.G.3    Bredberg, U.4    Benthem, B.5    Duker, G.6
  • 21
    • 73949146951 scopus 로고    scopus 로고
    • Physiologically based predictions of the impact of inhibition of intestinal and hepatic metabolism on human pharmacokinetics of CYP3A substrates
    • Fenneteau F, Poulin P, Nekka F. 2009. Physiologically based predictions of the impact of inhibition of intestinal and hepatic metabolism on human pharmacokinetics of CYP3A substrates. J Pharm Sci 99:486-514.
    • (2009) J Pharm Sci , vol.99 , pp. 486-514
    • Fenneteau, F.1    Poulin, P.2    Nekka, F.3
  • 22
    • 0036144815 scopus 로고    scopus 로고
    • Prediction of pharmacokinetics prior to in vivo studies. 1. Mechanism-based prediction of volume of distribution
    • Poulin P, Theil FP. 2002. Prediction of pharmacokinetics prior to in vivo studies. 1. Mechanism-based prediction of volume of distribution. J Pharm Sci 91:129-156.
    • (2002) J Pharm Sci , vol.91 , pp. 129-156
    • Poulin, P.1    Theil, F.P.2
  • 23
    • 2642536176 scopus 로고    scopus 로고
    • Volume of distribution at steady-state for a linear pharmacokinetic system with peripheral elimination
    • Berezhkovskiy LM. 2004. Volume of distribution at steady-state for a linear pharmacokinetic system with peripheral elimination. J Pharm Sci 93:1628-1640.
    • (2004) J Pharm Sci , vol.93 , pp. 1628-1640
    • Berezhkovskiy, L.M.1
  • 24
    • 34247556082 scopus 로고    scopus 로고
    • Mechanistic approaches to volume of distribution predictions: Understanding the processes
    • Rodgers T, Rowland M. 2007. Mechanistic approaches to volume of distribution predictions: Understanding the processes. Pharm Res 24:918-933.
    • (2007) Pharm Res , vol.24 , pp. 918-933
    • Rodgers, T.1    Rowland, M.2
  • 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
    • 0030003789 scopus 로고    scopus 로고
    • Estimation of the increase in solubility of drugs as a function of bile salt concentration
    • Mithani SD, Bakatselou V, TenHoor CN, Dressman JB. 1996. Estimation of the increase in solubility of drugs as a function of bile salt concentration. Pharm Res 13:163-167.
    • (1996) Pharm Res , vol.13 , pp. 163-167
    • Mithani, S.D.1    Bakatselou, V.2    TenHoor, C.N.3    Dressman, J.B.4
  • 28
    • 0027275566 scopus 로고
    • Physiological parameters in laboratory animals and humans
    • Davies B and Morris T. 1993. Physiological parameters in laboratory animals and humans. Pharm Res 10:1093-1095.
    • (1993) Pharm Res , vol.10 , pp. 1093-1095
    • Davies, B.1    Morris, T.2
  • 29
    • 0032733974 scopus 로고    scopus 로고
    • 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
    • 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 27:1350-1359.
    • (1999) Drug Metab Dispos , vol.27 , pp. 1350-1359
    • Obach, R.S.1
  • 30
    • 70350603410 scopus 로고    scopus 로고
    • Prediction of non-specific hepatic microsomal binding from readily available physicochemical properties
    • Turner DB, Rostami-Hodjegan A, Tucker GT, Yeo KR. 2007. Prediction of non-specific hepatic microsomal binding from readily available physicochemical properties. Drug Metab Disp 38 (S1):162-163.
    • (2007) Drug Metab Disp , vol.38 , Issue.S1 , pp. 162-163
    • Turner, D.B.1    Rostami-Hodjegan, A.2    Tucker, G.T.3    Yeo, K.R.4
  • 31
    • 23944515735 scopus 로고    scopus 로고
    • A novel model for prediction of human drug clearance by allometric scaling
    • Tang H, Mayersohn M. 2005. A novel model for prediction of human drug clearance by allometric scaling. Drug Metab Dispos 33:1297-1303.
    • (2005) Drug Metab Dispos , vol.33 , pp. 1297-1303
    • Tang, H.1    Mayersohn, M.2
  • 32
    • 34347396549 scopus 로고    scopus 로고
    • A unified approach for assessing agreement for continuous and categorical data
    • Lin L, Hedayat AS, Wu W. 2007. A unified approach for assessing agreement for continuous and categorical data. J Biopharm Stat 17:629-652.
    • (2007) J Biopharm Stat , vol.17 , pp. 629-652
    • Lin, L.1    Hedayat, A.S.2    Wu, W.3
  • 33
    • 78650529736 scopus 로고    scopus 로고
    • A hybrid approach to advancing quantitative prediction of tissue distribution of basic drugs in human
    • Poulin P, Ekin S, Theil FP. 2011. A hybrid approach to advancing quantitative prediction of tissue distribution of basic drugs in human. Toxicol Appl Pharmacol 250:194-212.
    • (2011) Toxicol Appl Pharmacol , vol.250 , pp. 194-212
    • Poulin, P.1    Ekin, S.2    Theil, F.P.3
  • 34
    • 72449122816 scopus 로고    scopus 로고
    • Measurement and prediction of oral absorption: A review
    • Keldenich J. 2009. Measurement and prediction of oral absorption: A review. Chem Biodivers 6:2000-2013.
    • (2009) Chem Biodivers , vol.6 , pp. 2000-2013
    • Keldenich, J.1
  • 35
    • 39149115065 scopus 로고    scopus 로고
    • Predicting drug disposition, transporter interplay and the role of food on drug absorption
    • Custodio JM, Wu CY, Benet LZ. 2008. Predicting drug disposition, transporter interplay and the role of food on drug absorption. Adv Drug Deliv Rev 60:717-733.
    • (2008) Adv Drug Deliv Rev , vol.60 , pp. 717-733
    • Custodio, J.M.1    Wu, C.Y.2    Benet, L.Z.3
  • 36
    • 77953729581 scopus 로고    scopus 로고
    • Interlay of dissolution, solubility, and nonsink permeation determines the oral absorption of the hedgehog pathway inhibitor GDC-0449 in dogs: An investigation using preclinical studies and physiologically based pharmacokinetic model
    • Cornelis ECA Hop
    • Wong W, Theil FP, Cui Y, Khojasteh SC, Marsters JC, Vernillet L, La H, Song X, Wang H, Morinello E, Deng Y, Cornelis ECA Hop. 2010. Interlay of dissolution, solubility, and nonsink permeation determines the oral absorption of the hedgehog pathway inhibitor GDC-0449 in dogs: An investigation using preclinical studies and physiologically based pharmacokinetic model. Drug Met Disp 38:1029-1038.
    • (2010) Drug Met Disp , vol.38 , pp. 1029-1038
    • Wong, W.1    Theil, F.P.2    Cui, Y.3    Khojasteh, S.C.4    Marsters, J.C.5    Vernillet, L.6    La, H.7    Song, X.8    Wang, H.9    Morinello, E.10    Deng, Y.11
  • 37
    • 0031786518 scopus 로고    scopus 로고
    • Linear correlation of the fraction of oral dose absorbed of 64 drugs between human and rats
    • Chiou WL, Barve A. 1998. Linear correlation of the fraction of oral dose absorbed of 64 drugs between human and rats. Pharm Res 15:1792-1795.
    • (1998) Pharm Res , vol.15 , pp. 1792-1795
    • Chiou, W.L.1    Barve, A.2
  • 39
    • 45849132066 scopus 로고    scopus 로고
    • Pre-clinical pharmacokinetics of UK-453,061, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), and use of in silico physiologically based prediction tools to predict the oral pharmacokinetics of UK-453,061 in man
    • Allan G, Davis J, Dickins M, Gardner I, Jenkins T. 2008. Pre-clinical pharmacokinetics of UK-453, 061, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), and use of in silico physiologically based prediction tools to predict the oral pharmacokinetics of UK-453, 061 in man. Xenobiotica 38:620-640.
    • (2008) Xenobiotica , vol.38 , pp. 620-640
    • Allan, G.1    Davis, J.2    Dickins, M.3    Gardner, I.4    Jenkins, T.5
  • 40
    • 70350521133 scopus 로고    scopus 로고
    • Prediction of Phase I single-dose pharmacokinetics using recombinant cytochromes P450 and physiologically based modeling
    • Gibson CR, Bergman A, Lu P, Kesisoglou F, Denney WS, Mulrooney E. 2009. Prediction of Phase I single-dose pharmacokinetics using recombinant cytochromes P450 and physiologically based modeling. Xenobiotica 39:637-648.
    • (2009) Xenobiotica , vol.39 , pp. 637-648
    • Gibson, C.R.1    Bergman, A.2    Lu, P.3    Kesisoglou, F.4    Denney, W.S.5    Mulrooney, E.6
  • 41
    • 56049112383 scopus 로고    scopus 로고
    • Applications of physiologically based absorption models in drug discovery and development
    • Parrott N, Lavé T. 2008. Applications of physiologically based absorption models in drug discovery and development. Mol Pharmaceutics 5:760-775.
    • (2008) Mol Pharmaceutics , vol.5 , pp. 760-775
    • Parrott, N.1    Lavé, T.2
  • 42
    • 65549103408 scopus 로고    scopus 로고
    • Predicting pharmacokinetics of drugs using physiologically-based modeling-Application to food effects
    • Parrott N, Lucakova V, Fraczkiewicz G, Bolger MB. 2009. Predicting pharmacokinetics of drugs using physiologically-based modeling-Application to food effects. AAPS 11:45-53.
    • (2009) AAPS , vol.11 , pp. 45-53
    • Parrott, N.1    Lucakova, V.2    Fraczkiewicz, G.3    Bolger, M.B.4
  • 43
    • 79951768576 scopus 로고    scopus 로고
    • Application of physiologically based pharmacokinetic modeling and clearance concept to drugs showing transporter-mediated distribution and clearance in humans
    • Watanabe T, Kusuhara H, Sugiyama Y. 2010. Application of physiologically based pharmacokinetic modeling and clearance concept to drugs showing transporter-mediated distribution and clearance in humans. J Pharmacokin Pharmacodyn 37: 575-590.
    • (2010) J Pharmacokin Pharmacodyn , vol.37 , pp. 575-590
    • Watanabe, T.1    Kusuhara, H.2    Sugiyama, Y.3
  • 44
    • 77957357276 scopus 로고    scopus 로고
    • Extrpolating in vitro metabolic interactions to isolated perfused liver: Prediction of metabolic interactions between bufarolol, bunitrolol and debrisoquine
    • Haddad S, Poulin P, Funk C. 2010. Extrpolating in vitro metabolic interactions to isolated perfused liver: Prediction of metabolic interactions between bufarolol, bunitrolol and debrisoquine. J Pharm Sci 99:4406-4426.
    • (2010) J Pharm Sci , vol.99 , pp. 4406-4426
    • Haddad, S.1    Poulin, P.2    Funk, C.3
  • 45
    • 77549084821 scopus 로고    scopus 로고
    • Physiologically based mechanistic modeling to predict complex drug-drug interactions involving simultaneous competitive and time-dependent enzyme inhibition by parent compound and its metabolite in both liver and gut-The effect of diltiazem on the time-course of exposure to triazolam
    • Rowland K Yeo, Jamei M, Yang J, Tucker GT, Rostami-Hodjegan A. 2010. Physiologically based mechanistic modeling to predict complex drug-drug interactions involving simultaneous competitive and time-dependent enzyme inhibition by parent compound and its metabolite in both liver and gut-The effect of diltiazem on the time-course of exposure to triazolam. Eur J Pharm Sci. 39:298-309.
    • (2010) Eur J Pharm Sci , vol.39 , pp. 298-309
    • Rowland, K.Y.1    Jamei, M.2    Yang, J.3    Tucker, G.T.4    Rostami-Hodjegan, A.5
  • 46
    • 0036996587 scopus 로고    scopus 로고
    • Physiological modeling and extrapolation of pharmacokinetic interactions from binary to more complex chemical mixtures
    • SUPPL
    • Krishnan K, Haddad S, Béliveau M, Tardif R. 2002. Physiological modeling and extrapolation of pharmacokinetic interactions from binary to more complex chemical mixtures. Environ Health Perspect. Suppl 6:989-94.
    • (2002) Environ Health Perspect , vol.6 , pp. 989-994
    • Krishnan, K.1    Haddad, S.2    Béliveau, M.3    Tardif, R.4
  • 47
    • 78149408459 scopus 로고    scopus 로고
    • A unified algorithm for predicting partition coefficients for PBPK modeling of drugs and environmental chemicals
    • Peyret T, Poulin P, Krishnan K. 2010. A unified algorithm for predicting partition coefficients for PBPK modeling of drugs and environmental chemicals. Toxicol Appl Pharmacol 249:197-207.
    • (2010) Toxicol Appl Pharmacol , vol.249 , pp. 197-207
    • Peyret, T.1    Poulin, P.2    Krishnan, K.3
  • 49
    • 79951765993 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic in drug development and regulatory science
    • Rowland M, Peck C, Tucker G. 2011. Physiologically based pharmacokinetic in drug development and regulatory science. Annu Rev Pharmacol Toxicol 51: 45-73.
    • (2011) Annu Rev Pharmacol Toxicol , vol.51 , pp. 45-73
    • Rowland, M.1    Peck, C.2    Tucker, G.3


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