메뉴 건너뛰기




Volumn 41, Issue 12, 2013, Pages 1194-2003

Impact of physiologically based pharmacokinetic modeling and simulation in drug development

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; GSK 1; GSK 19; GSK 2; GSK 20; GSK 21; GSK 22; GSK 23; GSK 28; GSK 29; GSK 3; GSK 30; GSK 31; GSK 32; GSK 33; GSK 34; GSK 35; GSK 36; GSK 37; GSK 38; GSK 39; GSK 40; GSK 41; GSK 5; GSK 6; KETOCONAZOLE; RIFAMPICIN; RITONAVIR; UNCLASSIFIED DRUG; UNINDEXED DRUG; DRUG;

EID: 84888624560     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.113.052803     Document Type: Article
Times cited : (32)

References (54)
  • 1
    • 0031028102 scopus 로고    scopus 로고
    • Effect of route of administration of fluconazole on the interaction between fluconazole and midazolam
    • Ahonen J, Olkkola KT, and Neuvonen PJ (1997) Effect of route of administration of fluconazole on the interaction between fluconazole and midazolam. Eur J Clin Pharmacol 51:415-419.
    • (1997) Eur J Clin Pharmacol , vol.51 , pp. 415-419
    • Ahonen, J.1    Olkkola, K.T.2    Neuvonen, P.J.3
  • 2
    • 68349150527 scopus 로고    scopus 로고
    • Towards a quantitative framework for the prediction of DDIs arising from cytochrome P450 induction
    • Almond LM, Yang J, Jamei M, Tucker GT, and Rostami-Hodjegan A (2009) Towards a quantitative framework for the prediction of DDIs arising from cytochrome P450 induction. Curr Drug Metab 10:420-432.
    • (2009) Curr Drug Metab , vol.10 , pp. 420-432
    • Almond, L.M.1    Yang, J.2    Jamei, M.3    Tucker, G.T.4    Rostami-Hodjegan, A.5
  • 3
    • 0016192808 scopus 로고
    • Lidocaine disposition kinetics in monkey and man. I. Prediction by a perfusion model
    • Benowitz N, Forsyth FP, Melmon KL, and Rowland M (1974) Lidocaine disposition kinetics in monkey and man. I. Prediction by a perfusion model. Clin Pharmacol Ther 16:87-98.
    • (1974) Clin Pharmacol Ther , vol.16 , pp. 87-98
    • Benowitz, N.1    Forsyth, F.P.2    Melmon, K.L.3    Rowland, M.4
  • 4
    • 0033927671 scopus 로고    scopus 로고
    • Measurement of cytochrome P450 gene induction in human hepatocytes using quantitative real-time reverse transcriptase-polymerase chain reaction
    • Bowen WP, Carey JE, Miah A, McMurray HF, Munday PW, James RS, Coleman RA, and Brown AM (2000) Measurement of cytochrome P450 gene induction in human hepatocytes using quantitative real-time reverse transcriptase-polymerase chain reaction. Drug Metab Dispos 28:781-788.
    • (2000) Drug Metab Dispos , vol.28 , pp. 781-788
    • Bowen, W.P.1    Carey, J.E.2    Miah, A.3    McMurray, H.F.4    Munday, P.W.5    James, R.S.6    Coleman, R.A.7    Brown, A.M.8
  • 8
    • 84896691884 scopus 로고    scopus 로고
    • The importance of villous physiology and morphology in mechanistic physiologically-based pharmacokinetic models
    • DOI: 10.1007/s11095-013-1161-x
    • Chen EP, Tai G, and Ellens H (2013) The importance of villous physiology and morphology in mechanistic physiologically-based pharmacokinetic models. Pharm Res DOI: 10.1007/s11095-013-1161-x.
    • (2013) Pharm Res
    • Chen, E.P.1    Tai, G.2    Ellens, H.3
  • 9
    • 67649404709 scopus 로고    scopus 로고
    • In vitro and in vivo induction of cytochrome p450: A survey of the current practices and recommendations: A pharmaceutical research and manufacturers of america perspective
    • Chu V, Einolf HJ, Evers R, Kumar G, Moore D, Ripp S, Silva J, Sinha V, Sinz M, and Skerjanec A (2009) In vitro and in vivo induction of cytochrome p450: a survey of the current practices and recommendations: a pharmaceutical research and manufacturers of america perspective. Drug Metab Dispos 37:1339-1354.
    • (2009) Drug Metab Dispos , vol.37 , pp. 1339-1354
    • Chu, V.1    Einolf, H.J.2    Evers, R.3    Kumar, G.4    Moore, D.5    Ripp, S.6    Silva, J.7    Sinha, V.8    Sinz, M.9    Skerjanec, A.10
  • 12
    • 79955690629 scopus 로고    scopus 로고
    • Committee for Human Medicinal Products (CHMP) [Final] London
    • Committee for Human Medicinal Products (CHMP) (2012) Guideline on the Investigation of Drug Interactions [Final], European Medicines Agency, London. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2012/ 07/WC500129606.pdf.
    • (2012) Guideline on the Investigation of Drug Interactions
  • 13
    • 37349017573 scopus 로고    scopus 로고
    • Physiologically based approaches towards the prediction of pharmacokinetics: In vitro-in vivo extrapolation
    • De Buck SS and Mackie CE (2007) Physiologically based approaches towards the prediction of pharmacokinetics: in vitro-in vivo extrapolation. Expert Opin Drug Metab Toxicol 3:865-878.
    • (2007) Expert Opin Drug Metab Toxicol , vol.3 , pp. 865-878
    • De Buck, S.S.1    Mackie, C.E.2
  • 14
    • 0025344378 scopus 로고
    • Cytochrome P 450 isoenzymes, epoxide hydrolase and glutathione transferases in rat and human hepatic and extrahepatic tissues
    • de Waziers I, Cugnenc PH, Yang CS, Leroux JP, and Beaune PH (1990) Cytochrome P 450 isoenzymes, epoxide hydrolase and glutathione transferases in rat and human hepatic and extrahepatic tissues. J Pharmacol Exp Ther 253:387-394.
    • (1990) J Pharmacol Exp Ther , vol.253 , pp. 387-394
    • De Waziers, I.1    Cugnenc, P.H.2    Yang, C.S.3    Leroux, J.P.4    Beaune, P.H.5
  • 15
    • 52649130373 scopus 로고    scopus 로고
    • Whole body physiologically-based pharmacokinetic models: Their use in clinical drug development
    • Edginton AN, Theil FP, Schmitt W, and Willmann S (2008) Whole body physiologically-based pharmacokinetic models: their use in clinical drug development. Expert Opin Drug Metab Toxicol 4:1143-1152.
    • (2008) Expert Opin Drug Metab Toxicol , vol.4 , pp. 1143-1152
    • Edginton, A.N.1    Theil, F.P.2    Schmitt, W.3    Willmann, S.4
  • 16
    • 35648968125 scopus 로고    scopus 로고
    • Comparison of different approaches to predict metabolic drug-drug interactions
    • Einolf HJ (2007) Comparison of different approaches to predict metabolic drug-drug interactions. Xenobiotica 37:1257-1294.
    • (2007) Xenobiotica , vol.37 , pp. 1257-1294
    • Einolf, H.J.1
  • 18
    • 67650825002 scopus 로고    scopus 로고
    • Comparison of different algorithms for predicting clinical drug-drug interactions, based on the use of CYP3A4 in vitro data: Predictions of compounds as precipitants of interaction
    • Fahmi OA, Hurst S, Plowchalk D, Cook J, Guo F, Youdim K, Dickins M, Phipps A, Darekar A, and Hyland R, et al. (2009) Comparison of different algorithms for predicting clinical drug-drug interactions, based on the use of CYP3A4 in vitro data: predictions of compounds as precipitants of interaction. Drug Metab Dispos 37:1658-1666.
    • (2009) Drug Metab Dispos , vol.37 , pp. 1658-1666
    • Fahmi, O.A.1    Hurst, S.2    Plowchalk, D.3    Cook, J.4    Guo, F.5    Youdim, K.6    Dickins, M.7    Phipps, A.8    Darekar, A.9    Hyland, R.10
  • 19
    • 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, and Nekka F (2010) 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) J Pharm Sci , vol.99 , pp. 486-514
    • Fenneteau, F.1    Poulin, P.2    Nekka, F.3
  • 21
    • 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 JA, Zhao P, Bullock J, Booth BP, Lu M, Robie-Suh K, Berglund EG, Pang KS, Rahman A, and Zhang L, et al. (2012) 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) Biopharm Drug Dispos , vol.33 , pp. 99-110
    • Grillo, J.A.1    Zhao, P.2    Bullock, J.3    Booth, B.P.4    Lu, M.5    Robie-Suh, K.6    Berglund, E.G.7    Pang, K.S.8    Rahman, A.9    Zhang, L.10
  • 22
    • 0017702743 scopus 로고
    • Physiologically based pharmacokinetic model for digoxin disposition in dogs and its preliminary application to humans
    • Harrison LI and Gibaldi M (1977) Physiologically based pharmacokinetic model for digoxin disposition in dogs and its preliminary application to humans. J Pharm Sci 66:1679-1683.
    • (1977) J Pharm Sci , vol.66 , pp. 1679-1683
    • Harrison, L.I.1    Gibaldi, M.2
  • 23
    • 70449440262 scopus 로고    scopus 로고
    • How much ritonavir is needed to boost protease inhibitors? Systematic review of 17 dose-ranging pharmacokinetic trials
    • Hill A, van der Lugt J, Sawyer W, and Boffito M (2009) How much ritonavir is needed to boost protease inhibitors? Systematic review of 17 dose-ranging pharmacokinetic trials. AIDS 23: 2237-2245.
    • (2009) AIDS , vol.23 , pp. 2237-2245
    • Hill, A.1    Van Der Lugt, J.2    Sawyer, W.3    Boffito, M.4
  • 24
    • 84863344719 scopus 로고    scopus 로고
    • PBPK as a tool in regulatory review
    • Huang S-M (2012) PBPK as a tool in regulatory review. Biopharm Drug Dispos 33:51-52.
    • (2012) Biopharm Drug Dispos , vol.33 , pp. 51-52
    • Huang, S.-M.1
  • 27
    • 46749154596 scopus 로고    scopus 로고
    • The quantitative prediction of CYP-mediated drug interaction by physiologically based pharmacokinetic modeling
    • Kato M, Shitara Y, Sato H, Yoshisue K, Hirano M, Ikeda T, and Sugiyama Y (2008) The quantitative prediction of CYP-mediated drug interaction by physiologically based pharmacokinetic modeling. Pharm Res 25:1891-1901.
    • (2008) Pharm Res , vol.25 , pp. 1891-1901
    • Kato, M.1    Shitara, Y.2    Sato, H.3    Yoshisue, K.4    Hirano, M.5    Ikeda, T.6    Sugiyama, Y.7
  • 30
    • 66649089506 scopus 로고    scopus 로고
    • Evaluation of multiple in vitro systems for assessment of CYP3A4 induction in drug discovery: Human hepatocytes, pregnane X receptor reporter gene, and Fa2N-4 and HepaRG cells
    • McGinnity DF, Zhang G, Kenny JR, Hamilton GA, Otmani S, Stams KR, Haney S, Brassil P, Stresser DM, and Riley RJ (2009) Evaluation of multiple in vitro systems for assessment of CYP3A4 induction in drug discovery: human hepatocytes, pregnane X receptor reporter gene, and Fa2N-4 and HepaRG cells. Drug Metab Dispos 37:1259-1268.
    • (2009) Drug Metab Dispos , vol.37 , pp. 1259-1268
    • McGinnity, D.F.1    Zhang, G.2    Kenny, J.R.3    Hamilton, G.A.4    Otmani, S.5    Stams, K.R.6    Haney, S.7    Brassil, P.8    Stresser, D.M.9    Riley, R.J.10
  • 31
    • 34447330544 scopus 로고    scopus 로고
    • Whole-body physiologically based pharmacokinetic models
    • Nestorov IA (2007) Whole-body physiologically based pharmacokinetic models. Expert Opin Drug Metab Toxicol 3:235-249.
    • (2007) Expert Opin Drug Metab Toxicol , vol.3 , pp. 235-249
    • Nestorov, I.A.1
  • 32
    • 33846449874 scopus 로고    scopus 로고
    • Mechanism-based inactivation of human cytochrome p450 enzymes and the prediction of drug-drug interactions
    • Obach RS, Walsky RL, and Venkatakrishnan K (2007) Mechanism-based inactivation of human cytochrome p450 enzymes and the prediction of drug-drug interactions. Drug Metab Dispos 35:246-255.
    • (2007) Drug Metab Dispos , vol.35 , pp. 246-255
    • Obach, R.S.1    Walsky, R.L.2    Venkatakrishnan, K.3
  • 34
    • 0037389914 scopus 로고    scopus 로고
    • Drug metabolism in chronic renal failure
    • Pichette V and Leblond FA (2003) Drug metabolism in chronic renal failure. Curr Drug Metab 4:91-103.
    • (2003) Curr Drug Metab , vol.4 , pp. 91-103
    • Pichette, V.1    Leblond, F.A.2
  • 35
    • 84872715452 scopus 로고    scopus 로고
    • Evaluation of drug interactions of GSK1292263 (a GPR119 agonist) with statins: From in vitro data to clinical study design
    • Polli JW, Hussey E, Bush M, Generaux G, Smith G, Collins D, McMullen S, Turner N, and Nunez DJ (2013) Evaluation of drug interactions of GSK1292263 (a GPR119 agonist) with statins: from in vitro data to clinical study design. Xenobiotica 43:498-508.
    • (2013) Xenobiotica , vol.43 , pp. 498-508
    • Polli, J.W.1    Hussey, E.2    Bush, M.3    Generaux, G.4    Smith, G.5    Collins, D.6    McMullen, S.7    Turner, N.8    Nunez, D.J.9
  • 36
    • 0036075799 scopus 로고    scopus 로고
    • Prediction of pharmacokinetics prior to in vivo studies. II. Generic physiologically based pharmacokinetic models of drug disposition
    • Poulin P and 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
  • 37
    • 0033105118 scopus 로고    scopus 로고
    • Integrated cytochrome P450 reaction phenotyping: Attempting to bridge the gap between cDNA-expressed cytochromes P450 and native human liver microsomes
    • Rodrigues AD (1999) Integrated cytochrome P450 reaction phenotyping: attempting to bridge the gap between cDNA-expressed cytochromes P450 and native human liver microsomes. Biochem Pharmacol 57:465-480.
    • (1999) Biochem Pharmacol , vol.57 , pp. 465-480
    • Rodrigues, A.D.1
  • 38
    • 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
  • 39
    • 33947587274 scopus 로고    scopus 로고
    • Simulation and prediction of in vivo drug metabolism in human populations from in vitro data
    • Rostami-Hodjegan A and Tucker GT (2007) Simulation and prediction of in vivo drug metabolism in human populations from in vitro data. Nat Rev Drug Discov 6:140-148.
    • (2007) Nat Rev Drug Discov , vol.6 , pp. 140-148
    • Rostami-Hodjegan, A.1    Tucker, G.T.2
  • 40
    • 79951765993 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetics in drug development and regulatory science
    • Rowland M, Peck C, and Tucker G (2011) Physiologically-based pharmacokinetics 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
  • 42
    • 79957493995 scopus 로고    scopus 로고
    • Prediction of time-dependent CYP3A4 drug-drug interactions by physiologically based pharmacokinetic modelling: Impact of inactivation parameters and enzyme turnover
    • Rowland Yeo KR, Walsky RL, Jamei M, Rostami-Hodjegan A, and Tucker GT (2011b) Prediction of time-dependent CYP3A4 drug-drug interactions by physiologically based pharmacokinetic modelling: impact of inactivation parameters and enzyme turnover. Eur J Pharm Sci 43:160-173.
    • (2011) Eur J Pharm Sci , vol.43 , pp. 160-173
    • Rowland Yeo, K.R.1    Walsky, R.L.2    Jamei, M.3    Rostami-Hodjegan, A.4    Tucker, G.T.5
  • 43
    • 80054734196 scopus 로고    scopus 로고
    • Utilizing drug-drug interaction prediction tools during drug development: Enhanced decision making based on clinical risk
    • Shardlow CE, Generaux GT, MacLauchlin CC, Pons N, Skordos KW, and Bloomer JC (2011) Utilizing drug-drug interaction prediction tools during drug development: enhanced decision making based on clinical risk. Drug Metab Dispos 39:2076-2084.
    • (2011) Drug Metab Dispos , vol.39 , pp. 2076-2084
    • Shardlow, C.E.1    Generaux, G.T.2    MacLauchlin, C.C.3    Pons, N.4    Skordos, K.W.5    Bloomer, J.C.6
  • 44
    • 0037452445 scopus 로고    scopus 로고
    • Utility of physiologically based pharmacokinetic models to drug development and rational drug discovery candidate selection
    • Theil FP, Guentert TW, Haddad S, and Poulin P (2003) Utility of physiologically based pharmacokinetic models to drug development and rational drug discovery candidate selection. Toxicol Lett 138:29-49.
    • (2003) Toxicol Lett , vol.138 , pp. 29-49
    • Theil, F.P.1    Guentert, T.W.2    Haddad, S.3    Poulin, P.4
  • 45
    • 0001146538 scopus 로고
    • Kinetics of distribution of substances administered to the body. I. The extravascular modes of administration
    • Teorell T (1937) Kinetics of distribution of substances administered to the body. I. The extravascular modes of administration. Arch Int Pharmacodyn Ther 57:202-225.
    • (1937) Arch Int Pharmacodyn Ther , vol.57 , pp. 202-225
    • Teorell, T.1
  • 46
    • 66149121105 scopus 로고    scopus 로고
    • Clinical review: Drug metabolism and nonrenal clearance in acute kidney injury
    • Vilay AM, Churchwell MD, and Mueller BA (2008) Clinical review: Drug metabolism and nonrenal clearance in acute kidney injury. Crit Care 12:235.
    • (2008) Crit Care , vol.12 , pp. 235
    • Vilay, A.M.1    Churchwell, M.D.2    Mueller, B.A.3
  • 47
    • 34247394165 scopus 로고    scopus 로고
    • Dynamically simulating the interaction of midazolam and the CYP3A4 inhibitor itraconazole using individual coupled whole-body physiologically-based pharmacokinetic (WB-PBPK) models
    • Vossen M, Sevestre M, Niederalt C, Jang IJ, Willmann S, and Edginton AN (2007) Dynamically simulating the interaction of midazolam and the CYP3A4 inhibitor itraconazole using individual coupled whole-body physiologically-based pharmacokinetic (WB-PBPK) models. Theor Biol Med Model 4:13.
    • (2007) Theor Biol Med Model , vol.4 , pp. 13
    • Vossen, M.1    Sevestre, M.2    Niederalt, C.3    Jang, I.J.4    Willmann, S.5    Edginton, A.N.6
  • 48
    • 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, and Sugiyama Y (2009) Physiologically based pharmacokinetic modeling to predict transporter-mediated clearance and distribution of pravastatin in humans. J Pharmacol Exp Ther 328:652-662.
    • (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
  • 49
    • 79959385329 scopus 로고    scopus 로고
    • Simulation of clinical drug-drug interactions from hepatocyte CYP3A4 induction data and its potential utility in trial designs
    • Xu Y, Zhou Y, Hayashi M, Shou M, and Skiles GL (2011) Simulation of clinical drug-drug interactions from hepatocyte CYP3A4 induction data and its potential utility in trial designs. Drug Metab Dispos 39:1139-1148.
    • (2011) Drug Metab Dispos , vol.39 , pp. 1139-1148
    • Xu, Y.1    Zhou, Y.2    Hayashi, M.3    Shou, M.4    Skiles, G.L.5
  • 50
    • 47749122616 scopus 로고    scopus 로고
    • Cytochrome p450 turnover: Regulation of synthesis and degradation, methods for determining rates, and implications for the prediction of drug interactions
    • Yang J, Liao M, Shou M, Jamei M, Yeo KR, Tucker GT, and Rostami-Hodjegan A (2008) Cytochrome p450 turnover: regulation of synthesis and degradation, methods for determining rates, and implications for the prediction of drug interactions. Curr Drug Metab 9:384-394.
    • (2008) Curr Drug Metab , vol.9 , pp. 384-394
    • Yang, J.1    Liao, M.2    Shou, M.3    Jamei, M.4    Yeo, K.R.5    Tucker, G.T.6    Rostami-Hodjegan, A.7
  • 52
    • 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, and Huang S-M (2012a) 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) Clin Pharmacol Ther , vol.92 , pp. 17-20
    • Zhao, P.1    Rowland, M.2    Huang, S.-M.3
  • 53
    • 84857239735 scopus 로고    scopus 로고
    • Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation
    • Zhao P, Vieira Mde L, Grillo JA, Song P, Wu TC, Zheng JH, Arya V, Berglund EG, Atkinson AJ, Jr, and Sugiyama Y, et al. (2012b) Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation. J Clin Pharmacol 52(Suppl):91S-108S
    • (2012) J Clin Pharmacol , vol.52 , Issue.SUPPL.
    • Zhao, P.1    Vieira, M.D.L.2    Grillo, J.A.3    Song, P.4    Wu, T.C.5    Zheng, J.H.6    Arya, V.7    Berglund, E.G.8    Atkinson Jr., A.J.9    Sugiyama, Y.10


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.