메뉴 건너뛰기




Volumn 97, Issue 3, 2015, Pages 247-262

Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

Author keywords

[No Author keywords available]

Indexed keywords

FLUVOXAMINE;

EID: 84927679943     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.37     Document Type: Review
Times cited : (388)

References (75)
  • 1
    • 0001146538 scopus 로고
    • Kinetics of distribution of substances administered to the body. I. The extravascular modes of administration
    • Teorell, T. Kinetics of distribution of substances administered to the body. I. The extravascular modes of administration. Arch. Int. Pharmacodyn. Ther. 57, 205–225 (1937).
    • (1937) Arch. Int. Pharmacodyn. Ther , vol.57 , pp. 205-225
    • Teorell, T.1
  • 5
    • 85070758753 scopus 로고    scopus 로고
    • Japan Ministry of Health, Labor and Welfare
    • Drug interaction guideline for drug development and labeling recommendations (draft). Japan Ministry of Health, Labor and Welfare, 2014.
    • (2014)
  • 6
    • 79951765993 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetics in drug development and regulatory science
    • Rowland, M., Peck, C. & Tucker, G. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu. Rev. Pharmacol. Toxicol. 51, 45–73 (2011).
    • (2011) Annu. Rev. Pharmacol. Toxicol , vol.51 , pp. 45-73
    • Rowland, M.1    Peck, C.2    Tucker, G.3
  • 7
    • 35648955151 scopus 로고    scopus 로고
    • Challenges and opportunities with modelling and simulation in drug discovery and drug development
    • Lavé, T., Parrott, N., Grimm, H.P., Fleury, A. & Reddy, M. Challenges and opportunities with modelling and simulation in drug discovery and drug development. Xenobiotica. 37, 1295–1310 (2007).
    • (2007) Xenobiotica , vol.37 , pp. 1295-1310
    • Lavé, T.1    Parrott, N.2    Grimm, H.P.3    Fleury, A.4    Reddy, M.5
  • 8
    • 84862777396 scopus 로고    scopus 로고
    • Application of IVIVE and PBPK modeling in prospective prediction of clinical pharmacokinetics: strategy and approach during the drug discovery phase with four case studies
    • Chen, Y., Jin, J.Y., Mukadam, S., Malhi, V. & Kenny, JR. Application of IVIVE and PBPK modeling in prospective prediction of clinical pharmacokinetics: strategy and approach during the drug discovery phase with four case studies. Biopharm. Drug Dispos. 33, 85–98 (2012).
    • (2012) Biopharm. Drug Dispos , vol.33 , pp. 85-98
    • Chen, Y.1    Jin, J.Y.2    Mukadam, S.3    Malhi, V.4    Kenny, J.R.5
  • 9
    • 84883409705 scopus 로고    scopus 로고
    • Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development
    • Jones, H.M. & Rowland-Yeo, K. Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development. CPT Pharmacometrics Syst. Pharmacol. 2, e63 (2013).
    • (2013) CPT Pharmacometrics Syst. Pharmacol , vol.2
    • Jones, H.M.1    Rowland-Yeo, K.2
  • 10
    • 33646124969 scopus 로고    scopus 로고
    • A novel strategy for physiologically based predictions of human pharmacokinetics
    • Jones, H.M., Parrott, N., Jorga, K. & Lavé, T. A novel strategy for physiologically based predictions of human pharmacokinetics. Clin. Pharmacokinet. 45, 511–542 (2006).
    • (2006) Clin. Pharmacokinet , vol.45 , pp. 511-542
    • Jones, H.M.1    Parrott, N.2    Jorga, K.3    Lavé, T.4
  • 11
    • 84858660647 scopus 로고    scopus 로고
    • From preclinical to human–prediction of oral absorption and drug-drug interaction potential using physiologically based pharmacokinetic (PBPK) modeling approach in an industrial setting: a workflow by using case example
    • Sinha, V.K., Snoeys, J., Osselaer, N.V., Peer, A.V., Mackie, C. & Heald, D. From preclinical to human–prediction of oral absorption and drug-drug interaction potential using physiologically based pharmacokinetic (PBPK) modeling approach in an industrial setting: a workflow by using case example. Biopharm. Drug Dispos. 33, 111–121 (2012).
    • (2012) Biopharm. Drug Dispos , vol.33 , pp. 111-121
    • Sinha, V.K.1    Snoeys, J.2    Osselaer, N.V.3    Peer, A.V.4    Mackie, C.5    Heald, D.6
  • 12
    • 41049104351 scopus 로고    scopus 로고
    • Early identification of drug-induced impairment of gastric emptying through physiologically based pharmacokinetic (PBPK) simulation of plasma concentration-time profiles in rat
    • Peters, S.A. & Hultin, L. Early identification of drug-induced impairment of gastric emptying through physiologically based pharmacokinetic (PBPK) simulation of plasma concentration-time profiles in rat. J. Pharmacokinet. Pharmacodyn. 35, 1–30 (2008).
    • (2008) J. Pharmacokinet. Pharmacodyn , vol.35 , pp. 1-30
    • Peters, S.A.1    Hultin, L.2
  • 13
    • 0035478779 scopus 로고    scopus 로고
    • Predicting the impact of physiological and biochemical processes on oral drug bioavailability
    • Agoram, B., Woltosz, W.S. & Bolger, M.B. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv. Drug Deliv. Rev. 50 (suppl. 1), S41–S67 (2001).
    • (2001) Adv. Drug Deliv. Rev , vol.50 , pp. S41-S67
    • Agoram, B.1    Woltosz, W.S.2    Bolger, M.B.3
  • 14
    • 3242778534 scopus 로고    scopus 로고
    • A physiological model for the estimation of the fraction dose absorbed in humans
    • Willmann, S., Schmitt, W., Keldenich, J., Lippert, J. & Dressman, J.B. A physiological model for the estimation of the fraction dose absorbed in humans. J. Med. Chem. 47, 4022–4031 (2004).
    • (2004) J. Med. Chem , vol.47 , pp. 4022-4031
    • Willmann, S.1    Schmitt, W.2    Keldenich, J.3    Lippert, J.4    Dressman, J.B.5
  • 15
    • 65549089670 scopus 로고    scopus 로고
    • Introduction to computational oral absorption simulation
    • Sugano, K. Introduction to computational oral absorption simulation. Expert Opin. Drug Metab. Toxicol. 5, 259–293 (2009).
    • (2009) Expert Opin. Drug Metab. Toxicol , vol.5 , pp. 259-293
    • Sugano, K.1
  • 16
    • 40549113994 scopus 로고    scopus 로고
    • Evaluation of a generic physiologically based pharmacokinetic model for lineshape analysis
    • Peters, S.A. Evaluation of a generic physiologically based pharmacokinetic model for lineshape analysis. Clin. Pharmacokinet. 47, 261–275 (2008).
    • (2008) Clin. Pharmacokinet , vol.47 , pp. 261-275
    • Peters, S.A.1
  • 17
    • 79951774366 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetic modeling for absorption, transport, metabolism and excretion
    • Pang, K.S. & Durk, M.R. Physiologically-based pharmacokinetic modeling for absorption, transport, metabolism and excretion. J. Pharmacokinet. Pharmacodyn. 37, 591–615 (2010).
    • (2010) J. Pharmacokinet. Pharmacodyn , vol.37 , pp. 591-615
    • Pang, K.S.1    Durk, M.R.2
  • 18
    • 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. 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 (2010).
    • (2010) J. Pharm. Sci , vol.99 , pp. 486-514
    • Fenneteau, F.1    Poulin, P.2    Nekka, F.3
  • 19
    • 84890192826 scopus 로고    scopus 로고
    • Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compound
    • Xia, B. et al. Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compound. AAPS PharmSciTech. 14, 1255–1266 (2013).
    • (2013) AAPS PharmSciTech , vol.14 , pp. 1255-1266
    • Xia, B.1
  • 20
    • 40549096396 scopus 로고    scopus 로고
    • Identification of intestinal loss of a drug through physiologically based pharmacokinetic simulation of plasma concentration-time profiles
    • Peters, S.A. Identification of intestinal loss of a drug through physiologically based pharmacokinetic simulation of plasma concentration-time profiles. Clin. Pharmacokinet. 47, 245–259 (2008).
    • (2008) Clin. Pharmacokinet , vol.47 , pp. 245-259
    • Peters, S.A.1
  • 21
    • 0027275566 scopus 로고
    • Physiological parameters in laboratory animals and humans
    • Davies, B. & Morris, T. Physiological parameters in laboratory animals and humans. Pharm. Res. 10, 1093–1095 (1993).
    • (1993) Pharm. Res , vol.10 , pp. 1093-1095
    • Davies, B.1    Morris, T.2
  • 22
    • 0026015774 scopus 로고
    • Physiologic modeling of cyclosporin kinetics in rat and man
    • Bernareggi, A. & Rowland, M. Physiologic modeling of cyclosporin kinetics in rat and man. J. Pharmacokinet. Biopharm. 19, 21–50 (1991).
    • (1991) J. Pharmacokinet. Biopharm , vol.19 , pp. 21-50
    • Bernareggi, A.1    Rowland, M.2
  • 25
    • 84876284544 scopus 로고    scopus 로고
    • A physiologically based pharmacokinetic (PBPK) approach to evaluate pharmacokinetics in patients with cancer
    • Cheeti, S., Budha, N.R., Rajan, S., Dresser, M.J. & Jin, J.Y. A physiologically based pharmacokinetic (PBPK) approach to evaluate pharmacokinetics in patients with cancer. Biopharm. Drug Dispos. 34, 141–154 (2013).
    • (2013) Biopharm. Drug Dispos , vol.34 , pp. 141-154
    • Cheeti, S.1    Budha, N.R.2    Rajan, S.3    Dresser, M.J.4    Jin, J.Y.5
  • 26
    • 84888592045 scopus 로고    scopus 로고
    • Differences in cytochrome p450-mediated pharmacokinetics between Chinese and caucasian populations predicted by mechanistic physiologically based pharmacokinetic modelling
    • Barter, Z.E., Tucker, G.T. & Rowland-Yeo, K. Differences in cytochrome p450-mediated pharmacokinetics between Chinese and caucasian populations predicted by mechanistic physiologically based pharmacokinetic modelling. Clin. Pharmacokinet. 52, 1085–1100 (2013).
    • (2013) Clin. Pharmacokinet , vol.52 , pp. 1085-1100
    • Barter, Z.E.1    Tucker, G.T.2    Rowland-Yeo, K.3
  • 27
    • 0037364162 scopus 로고    scopus 로고
    • ADMET in silico modelling: towards prediction paradise?
    • van de Waterbeemd, H. & Gifford, E. ADMET in silico modelling: towards prediction paradise? Nat. Rev. Drug Discov. 2, 192–204 (2003).
    • (2003) Nat. Rev. Drug Discov , vol.2 , pp. 192-204
    • van de Waterbeemd, H.1    Gifford, E.2
  • 28
    • 27944458924 scopus 로고    scopus 로고
    • An evaluation of the utility of physiologically based models of pharmacokinetics in early drug discovery
    • Parrott, N., Paquereau, N., Coassolo, P. & Lavé, T. An evaluation of the utility of physiologically based models of pharmacokinetics in early drug discovery. J. Pharm. Sci. 94, 2327–2343 (2005).
    • (2005) J. Pharm. Sci , vol.94 , pp. 2327-2343
    • Parrott, N.1    Paquereau, N.2    Coassolo, P.3    Lavé, T.4
  • 29
    • 80052262709 scopus 로고    scopus 로고
    • 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
    • Poulin, P. et al. 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. J. Pharm. Sci. 100, 4127–4157 (2011).
    • (2011) J. Pharm. Sci , vol.100 , pp. 4127-4157
    • Poulin, P.1
  • 30
    • 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, S.S., Sinha, V.K., Fenu, L.A., Gilissen, R.A., Mackie, C.E. & Nijsen, M.J. 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).
    • (2007) Drug Metab. Dispos , vol.35 , pp. 649-659
    • De Buck, S.S.1    Sinha, V.K.2    Fenu, L.A.3    Gilissen, R.A.4    Mackie, C.E.5    Nijsen, M.J.6
  • 31
    • 56049112383 scopus 로고    scopus 로고
    • Applications of physiologically based absorption models in drug discovery and development
    • Parrott, N. & Lave, T. Applications of physiologically based absorption models in drug discovery and development. Mol. Pharm. 5, 760–775 (2008).
    • (2008) Mol. Pharm , vol.5 , pp. 760-775
    • Parrott, N.1    Lave, T.2
  • 32
    • 79953296456 scopus 로고    scopus 로고
    • Simulation of human intravenous and oral pharmacokinetics of 21 diverse compounds using physiologically based pharmacokinetic modelling
    • Jones, H.M. et al. Simulation of human intravenous and oral pharmacokinetics of 21 diverse compounds using physiologically based pharmacokinetic modelling. Clin. Pharmacokinet. 50, 331–347 (2011).
    • (2011) Clin. Pharmacokinet , vol.50 , pp. 331-347
    • Jones, H.M.1
  • 33
    • 67649958146 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic (PBPK) modeling and simulation: applications in lead optimization
    • Peters, S.A., Ungell, A.L. & Dolgos, H. Physiologically based pharmacokinetic (PBPK) modeling and simulation: applications in lead optimization. Curr. Opin. Drug Discov. Devel. 12, 509–518 (2009).
    • (2009) Curr. Opin. Drug Discov. Devel , vol.12 , pp. 509-518
    • Peters, S.A.1    Ungell, A.L.2    Dolgos, H.3
  • 34
    • 84906848489 scopus 로고    scopus 로고
    • Deciding on success criteria for predictability of pharmacokinetic parameters from in vitro studies: an analysis based on in vivo observations
    • Abduljalil, K., Cain, T., Humphries, H. & Rostami-Hodjegan, A. Deciding on success criteria for predictability of pharmacokinetic parameters from in vitro studies: an analysis based on in vivo observations. Drug Metab. Dispos. 42, 1478–1484 (2014).
    • (2014) Drug Metab. Dispos , vol.42 , pp. 1478-1484
    • Abduljalil, K.1    Cain, T.2    Humphries, H.3    Rostami-Hodjegan, A.4
  • 35
    • 82955193794 scopus 로고    scopus 로고
    • Application of PBPK modelling in drug discovery and development at Pfizer
    • Jones, H.M. et al. Application of PBPK modelling in drug discovery and development at Pfizer. Xenobiotica. 42, 94–106 (2012).
    • (2012) Xenobiotica , vol.42 , pp. 94-106
    • Jones, H.M.1
  • 36
    • 73349092713 scopus 로고    scopus 로고
    • Practical anticipation of human efficacious doses and pharmacokinetics using in vitro and preclinical in vivo data
    • Heimbach, T., Lakshminarayana, S.B., Hu, W. & He, H. Practical anticipation of human efficacious doses and pharmacokinetics using in vitro and preclinical in vivo data. AAPS J. 11, 602–614 (2009).
    • (2009) AAPS J , vol.11 , pp. 602-614
    • Heimbach, T.1    Lakshminarayana, S.B.2    Hu, W.3    He, H.4
  • 37
    • 84888624560 scopus 로고    scopus 로고
    • Impact of physiologically based pharmacokinetic modeling and simulation in drug development
    • Shardlow, C.E., Generaux, G.T., Patel, A.H., Tai, G., Tran, T. & Bloomer, J.C. Impact of physiologically based pharmacokinetic modeling and simulation in drug development. Drug Metab. Dispos. 41, 1994–2003 (2013).
    • (2013) Drug Metab. Dispos , vol.41 , pp. 1994-2003
    • Shardlow, C.E.1    Generaux, G.T.2    Patel, A.H.3    Tai, G.4    Tran, T.5    Bloomer, J.C.6
  • 39
    • 34547163963 scopus 로고    scopus 로고
    • Saturable uptake of lipophilic amine drugs into isolated hepatocytes: mechanisms and consequences for quantitative clearance prediction
    • Hallifax, D. & Houston, J.B. Saturable uptake of lipophilic amine drugs into isolated hepatocytes: mechanisms and consequences for quantitative clearance prediction. Drug Metab. Dispos. 35, 1325–1332 (2007).
    • (2007) Drug Metab. Dispos , vol.35 , pp. 1325-1332
    • Hallifax, D.1    Houston, J.B.2
  • 40
    • 79251546082 scopus 로고    scopus 로고
    • The corrected traditional equations for calculation of hepatic clearance that account for the difference in drug ionization in extracellular and intracellular tissue water and the corresponding corrected PBPK equation
    • Berezhkovskiy, L.M. The corrected traditional equations for calculation of hepatic clearance that account for the difference in drug ionization in extracellular and intracellular tissue water and the corresponding corrected PBPK equation. J. Pharm. Sci. 100, 1167–1183 (2011).
    • (2011) J. Pharm. Sci , vol.100 , pp. 1167-1183
    • Berezhkovskiy, L.M.1
  • 41
    • 79955033811 scopus 로고    scopus 로고
    • Reevaluation of the microsomal metabolism of montelukast: major contribution by CYP2C8 at clinically relevant concentrations
    • Filppula, A.M., Laitila, J., Neuvonen, P.J. & Backman, J.T. Reevaluation of the microsomal metabolism of montelukast: major contribution by CYP2C8 at clinically relevant concentrations. Drug Metab. Dispos. 39, 904–911 (2011).
    • (2011) Drug Metab. Dispos , vol.39 , pp. 904-911
    • Filppula, A.M.1    Laitila, J.2    Neuvonen, P.J.3    Backman, J.T.4
  • 42
    • 84896765551 scopus 로고    scopus 로고
    • Evaluating systems pharmacology models is different from evaluating standard pharmacokinetic-pharmacodynamic models
    • Agoram, B. Evaluating systems pharmacology models is different from evaluating standard pharmacokinetic-pharmacodynamic models. CPT Pharmacometrics Syst. Pharmacol. 3, e101 (2014).
    • (2014) CPT Pharmacometrics Syst. Pharmacol , vol.3
    • Agoram, B.1
  • 43
    • 78650054715 scopus 로고    scopus 로고
    • Simultaneous absolute quantification of 11 cytochrome P450 isoforms in human liver microsomes by liquid chromatography tandem mass spectrometry with in silico target peptide selection
    • Kawakami, H., Ohtsuki, S., Kamiie, J., Suzuki, T., Abe, T. & Terasaki, T. Simultaneous absolute quantification of 11 cytochrome P450 isoforms in human liver microsomes by liquid chromatography tandem mass spectrometry with in silico target peptide selection. J. Pharm. Sci. 100, 341–352 (2011).
    • (2011) J. Pharm. Sci , vol.100 , pp. 341-352
    • Kawakami, H.1    Ohtsuki, S.2    Kamiie, J.3    Suzuki, T.4    Abe, T.5    Terasaki, T.6
  • 44
    • 43049114146 scopus 로고    scopus 로고
    • Quantitative atlas of membrane transporter proteins: development and application of a highly sensitive simultaneous LC/MS/MS method combined with novel in-silico peptide selection criteria
    • Kamiie, J. et al. Quantitative atlas of membrane transporter proteins: development and application of a highly sensitive simultaneous LC/MS/MS method combined with novel in-silico peptide selection criteria. Pharm. Res. 25, 1469–1483 (2008).
    • (2008) Pharm. Res , vol.25 , pp. 1469-1483
    • Kamiie, J.1
  • 45
    • 57349162183 scopus 로고    scopus 로고
    • Design, data analysis, and simulation of in vitro drug transport kinetic experiments using a mechanistic in vitro model
    • Poirier, A. et al. Design, data analysis, and simulation of in vitro drug transport kinetic experiments using a mechanistic in vitro model. Drug Metab. Dispos. 36, 2434–2444 (2008).
    • (2008) Drug Metab. Dispos , vol.36 , pp. 2434-2444
    • Poirier, A.1
  • 46
    • 84859910816 scopus 로고    scopus 로고
    • Mechanistic pharmacokinetic modeling for the prediction of transporter-mediated disposition in humans from sandwich culture human hepatocyte data
    • Jones, H.M. et al. Mechanistic pharmacokinetic modeling for the prediction of transporter-mediated disposition in humans from sandwich culture human hepatocyte data. Drug Metab. Dispos. 40, 1007–1017 (2012).
    • (2012) Drug Metab. Dispos , vol.40 , pp. 1007-1017
    • Jones, H.M.1
  • 47
    • 59649130318 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic modeling to predict transporter-mediated clearance and distribution of pravastatin in humans
    • Watanabe, T., Kusuhara, H., Maeda, K., Shitara, Y. & Sugiyama, Y. Physiologically based pharmacokinetic modeling to predict transporter-mediated clearance and distribution of pravastatin in humans. J. Pharmacol. Exp. Ther. 328, 652–662 (2009).
    • (2009) J. Pharmacol. Exp. Ther , vol.328 , pp. 652-662
    • Watanabe, T.1    Kusuhara, H.2    Maeda, K.3    Shitara, Y.4    Sugiyama, Y.5
  • 48
    • 77952236114 scopus 로고    scopus 로고
    • Prediction of food effect by bile micelles on oral drug absorption considering free fraction in intestinal fluid
    • Sugano, K., Kataoka, M., Mathews Cda, C. & Yamashita, S. Prediction of food effect by bile micelles on oral drug absorption considering free fraction in intestinal fluid. Eur. J. Pharm. Sci. 40, 118–124 (2010).
    • (2010) Eur. J. Pharm. Sci , vol.40 , pp. 118-124
    • Sugano, K.1    Kataoka, M.2    Mathews Cda, C.3    Yamashita, S.4
  • 49
    • 84879468832 scopus 로고    scopus 로고
    • In silico predictions of gastrointestinal drug absorption in pharmaceutical product development: application of the mechanistic absorption model GI-Sim
    • Sjögren, E. et al. In silico predictions of gastrointestinal drug absorption in pharmaceutical product development: application of the mechanistic absorption model GI-Sim. Eur. J. Pharm. Sci. 49, 679–698 (2013).
    • (2013) Eur. J. Pharm. Sci , vol.49 , pp. 679-698
    • Sjögren, E.1
  • 50
    • 79954996910 scopus 로고    scopus 로고
    • In vivo investigation in pigs of intestinal absorption, hepatobiliary disposition, and metabolism of the 5α-reductase inhibitor finasteride and the effects of coadministered ketoconazole
    • Lundahl, A., Hedeland, M., Bondesson, U. & Lennernäs, H., In vivo investigation in pigs of intestinal absorption, hepatobiliary disposition, and metabolism of the 5α-reductase inhibitor finasteride and the effects of coadministered ketoconazole. Drug Metab. Dispos. 39, 847–857 (2011).
    • (2011) Drug Metab. Dispos , vol.39 , pp. 847-857
    • Lundahl, A.1    Hedeland, M.2    Bondesson, U.3    Lennernäs, H.4
  • 51
    • 84866461807 scopus 로고    scopus 로고
    • Commentary: theoretical predictions of flow effects on intestinal and systemic availability in physiologically based pharmacokinetic intestine models: the traditional model, segregated flow model, and QGut model
    • Pang, K.S. & Chow, E.C. Commentary: theoretical predictions of flow effects on intestinal and systemic availability in physiologically based pharmacokinetic intestine models: the traditional model, segregated flow model, and QGut model. Drug Metab. Dispos. 40, 1869–1877 (2012).
    • (2012) Drug Metab. Dispos , vol.40 , pp. 1869-1877
    • Pang, K.S.1    Chow, E.C.2
  • 52
    • 68249155031 scopus 로고    scopus 로고
    • Population-based mechanistic prediction of oral drug absorption
    • Jamei, M. et al. Population-based mechanistic prediction of oral drug absorption. AAPS J. 11, 225–237 (2009).
    • (2009) AAPS J , vol.11 , pp. 225-237
    • Jamei, M.1
  • 53
    • 80054738759 scopus 로고    scopus 로고
    • Evolution of a detailed physiological model to simulate the gastrointestinal transit and absorption process in humans, part 1: oral solutions
    • Thelen, K., Coboeken, K., Willmann, S., Burghaus, R., Dressman, J.B. & Lippert, J. Evolution of a detailed physiological model to simulate the gastrointestinal transit and absorption process in humans, part 1: oral solutions. J. Pharm. Sci. 100, 5324–5345 (2011).
    • (2011) J. Pharm. Sci , vol.100 , pp. 5324-5345
    • Thelen, K.1    Coboeken, K.2    Willmann, S.3    Burghaus, R.4    Dressman, J.B.5    Lippert, J.6
  • 54
    • 84858016380 scopus 로고    scopus 로고
    • In silico modeling for the nonlinear absorption kinetics of UK-343,664: a P-gp and CYP3A4 substrate
    • Abuasal, B.S., Bolger, M.B., Walker, D.K. & Kaddoumi, A. In silico modeling for the nonlinear absorption kinetics of UK-343,664: a P-gp and CYP3A4 substrate. Mol. Pharm. 9, 492–504 (2012).
    • (2012) Mol. Pharm , vol.9 , pp. 492-504
    • Abuasal, B.S.1    Bolger, M.B.2    Walker, D.K.3    Kaddoumi, A.4
  • 55
    • 44749087279 scopus 로고    scopus 로고
    • Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update
    • Jantratid, E., Janssen, N., Reppas, C. & Dressman, J.B. Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm. Res. 25, 1663–1676 (2008).
    • (2008) Pharm. Res , vol.25 , pp. 1663-1676
    • Jantratid, E.1    Janssen, N.2    Reppas, C.3    Dressman, J.B.4
  • 56
    • 77955656443 scopus 로고    scopus 로고
    • Forecasting in vivo oral absorption and food effect of micronized and nanosized aprepitant formulations in humans
    • Shono, Y., Jantratid, E., Kesisoglou, F., Reppas, C. & Dressman, J.B. Forecasting in vivo oral absorption and food effect of micronized and nanosized aprepitant formulations in humans. Eur. J. Pharm. Biopharm. 76, 95–104 (2010).
    • (2010) Eur. J. Pharm. Biopharm , vol.76 , pp. 95-104
    • Shono, Y.1    Jantratid, E.2    Kesisoglou, F.3    Reppas, C.4    Dressman, J.B.5
  • 57
    • 84871957696 scopus 로고    scopus 로고
    • Case studies for practical food effect assessments across BCS/BDDCS class compounds using in silico, in vitro, and preclinical in vivo data
    • Heimbach, T., Xia, B., Lin, T.H. & He, H. Case studies for practical food effect assessments across BCS/BDDCS class compounds using in silico, in vitro, and preclinical in vivo data. AAPS J. 15, 143–158 (2013).
    • (2013) AAPS J , vol.15 , pp. 143-158
    • Heimbach, T.1    Xia, B.2    Lin, T.H.3    He, H.4
  • 58
    • 43249097007 scopus 로고    scopus 로고
    • Designing biorelevant dissolution tests for lipid formulations: case example–lipid suspension of RZ-50
    • Jantratid, E., Janssen, N., Chokshi, H., Tang, K. & Dressman, J.B. Designing biorelevant dissolution tests for lipid formulations: case example–lipid suspension of RZ-50. Eur. J. Pharm. Biopharm. 69, 776–785 (2008).
    • (2008) Eur. J. Pharm. Biopharm , vol.69 , pp. 776-785
    • Jantratid, E.1    Janssen, N.2    Chokshi, H.3    Tang, K.4    Dressman, J.B.5
  • 59
    • 85070755479 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetic (PBPK) model for pulmonary drug delivery
    • &, 2013 AAPS, San Antonio, TX, November 2013
    • Larsson, K. & Peters, S.A. Physiologically-based pharmacokinetic (PBPK) model for pulmonary drug delivery. 2013 AAPS Annual Meeting and Exposition, San Antonio, TX, November 2013.
    • Annual Meeting and Exposition
    • Larsson, K.1    Peters, S.A.2
  • 60
    • 0028885668 scopus 로고
    • Biodistribution of monoclonal antibodies: scale-up from mouse to human using a physiologically based pharmacokinetic model
    • Baxter, L.T., Zhu, H., Mackensen, D.G., Butler, W.F. & Jain, R.K. Biodistribution of monoclonal antibodies: scale-up from mouse to human using a physiologically based pharmacokinetic model. Cancer Res. 55, 4611–4622 (1995).
    • (1995) Cancer Res , vol.55 , pp. 4611-4622
    • Baxter, L.T.1    Zhu, H.2    Mackensen, D.G.3    Butler, W.F.4    Jain, R.K.5
  • 61
    • 29144457336 scopus 로고    scopus 로고
    • 3rd. A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn)
    • Ferl, G.Z., Wu, A.M. & DiStefano, J.J. 3rd. A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn). Ann. Biomed. Eng. 33, 1640–1652 (2005).
    • (2005) Ann. Biomed. Eng , vol.33 , pp. 1640-1652
    • Ferl, G.Z.1    Wu, A.M.2    DiStefano, J.J.3
  • 62
    • 34748877223 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice
    • Garg, A. & Balthasar, J.P. Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J. Pharmacokinet. Pharmacodyn. 34, 687–709 (2007).
    • (2007) J. Pharmacokinet. Pharmacodyn , vol.34 , pp. 687-709
    • Garg, A.1    Balthasar, J.P.2
  • 63
    • 84861480783 scopus 로고    scopus 로고
    • Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human
    • Shah, D.K. & Betts, A.M. Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human. J. Pharmacokinet. Pharmacodyn. 39, 67–86 (2012).
    • (2012) J. Pharmacokinet. Pharmacodyn , vol.39 , pp. 67-86
    • Shah, D.K.1    Betts, A.M.2
  • 64
    • 84861666335 scopus 로고    scopus 로고
    • Local versus systemic anti-tumour necrosis factor-α effects of adalimumab in rheumatoid arthritis: pharmacokinetic modelling analysis of interaction between a soluble target and a drug
    • Stepensky, D. Local versus systemic anti-tumour necrosis factor-α effects of adalimumab in rheumatoid arthritis: pharmacokinetic modelling analysis of interaction between a soluble target and a drug. Clin. Pharmacokinet. 51, 443–455 (2012).
    • (2012) Clin. Pharmacokinet , vol.51 , pp. 443-455
    • Stepensky, D.1
  • 65
    • 66049094734 scopus 로고    scopus 로고
    • In vivo regulation of interleukin 1beta in patients with cryopyrin-associated periodic syndromes
    • Lachmann, H.J. et al. In vivo regulation of interleukin 1beta in patients with cryopyrin-associated periodic syndromes. J. Exp. Med. 206, 1029–1036 (2009).
    • (2009) J. Exp. Med , vol.206 , pp. 1029-1036
    • Lachmann, H.J.1
  • 66
    • 79951997839 scopus 로고    scopus 로고
    • The pharmacokinetic/pharmacodynamic pipeline: translating anticancer drug pharmacology to the clinic
    • Zhou, Q. & Gallo, J.M. The pharmacokinetic/pharmacodynamic pipeline: translating anticancer drug pharmacology to the clinic. AAPS J. 13, 111–120 (2011).
    • (2011) AAPS J , vol.13 , pp. 111-120
    • Zhou, Q.1    Gallo, J.M.2
  • 67
    • 84877074929 scopus 로고    scopus 로고
    • Dose selection based on physiologically based pharmacokinetic (PBPK) approaches
    • Jones, H.M., Mayawala, K. & Poulin, P. Dose selection based on physiologically based pharmacokinetic (PBPK) approaches. AAPS J. 15, 377–387 (2013).
    • (2013) AAPS J , vol.15 , pp. 377-387
    • Jones, H.M.1    Mayawala, K.2    Poulin, P.3
  • 69
    • 84862634533 scopus 로고    scopus 로고
    • Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions
    • Zhao, P., Rowland, M. & Huang, S.M. Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin. Pharmacol. Ther. 92, 17–20 (2012).
    • (2012) Clin. Pharmacol. Ther , vol.92 , pp. 17-20
    • Zhao, P.1    Rowland, M.2    Huang, S.M.3
  • 70
    • 84859994663 scopus 로고    scopus 로고
    • Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials
    • Leong, R. et al. Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials. Clin. Pharmacol. Ther. 91, 926–931 (2012).
    • (2012) Clin. Pharmacol. Ther , vol.91 , pp. 926-931
    • Leong, R.1
  • 71
    • 84862776909 scopus 로고    scopus 로고
    • Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice
    • Grillo, J.A. et al. Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice. Biopharm. Drug Dispos. 33, 99–110 (2012).
    • (2012) Biopharm. Drug Dispos , vol.33 , pp. 99-110
    • Grillo, J.A.1
  • 72
    • 84862777920 scopus 로고    scopus 로고
    • The role of physiologically based pharmacokinetic modeling in regulatory review
    • Huang, S.M. & Rowland, M. The role of physiologically based pharmacokinetic modeling in regulatory review. Clin. Pharmacol. Ther. 91, 542–549 (2012).
    • (2012) Clin. Pharmacol. Ther , vol.91 , pp. 542-549
    • Huang, S.M.1    Rowland, M.2
  • 73
    • 78951482203 scopus 로고    scopus 로고
    • Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review
    • Zhao, P. et al. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin. Pharmacol. Ther. 89, 259–267 (2011).
    • (2011) Clin. Pharmacol. Ther , vol.89 , pp. 259-267
    • Zhao, P.1
  • 74
    • 84881613954 scopus 로고    scopus 로고
    • The utility of modeling and simulation in drug development and regulatory review
    • Huang, S.M., Abernethy, D.R., Wang, Y., Zhao, P. & Zineh, I. The utility of modeling and simulation in drug development and regulatory review. J. Pharm. Sci. 102, 2912–2923 (2013).
    • (2013) J. Pharm. Sci , vol.102 , pp. 2912-2923
    • Huang, S.M.1    Abernethy, D.R.2    Wang, Y.3    Zhao, P.4    Zineh, I.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.