메뉴 건너뛰기




Volumn 38, Issue 7, 2010, Pages 1094-1104

Confidence assessment of the Simcyp time-based approach and a static mathematical model in predicting clinical drug-drug interactions for mechanism-based CYP3A inhibitors

Author keywords

[No Author keywords available]

Indexed keywords

ALPRAZOLAM; CLARITHROMYCIN; CYTOCHROME P450 3A; CYTOCHROME P450 INHIBITOR; DILTIAZEM; ERYTHROMYCIN; FLUOXETINE; MIDAZOLAM; NIFEDIPINE; RITONAVIR; SAQUINAVIR; SILDENAFIL; SIMVASTATIN; TRIAZOLAM; VERAPAMIL; ZOLPIDEM; CYP3A PROTEIN, HUMAN; CYTOCHROME P450 3A INHIBITOR;

EID: 77953787344     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.110.032177     Document Type: Article
Times cited : (80)

References (59)
  • 1
    • 0031868906 scopus 로고    scopus 로고
    • Minimal interaction between fluoxetine and multiple-dose zolpidem in healthy women
    • Allard S, Sainati S, Roth-Schechter B, and MacIntyre J (1998) Minimal interaction between fluoxetine and multiple-dose zolpidem in healthy women. Drug Metab Dispos 26:617-622. (Pubitemid 28345844)
    • (1998) Drug Metabolism and Disposition , vol.26 , Issue.7 , pp. 617-622
    • Allard, S.1    Sainati, S.2    Roth-Schechter, B.3    Macintyre, J.4
  • 5
    • 0026694007 scopus 로고
    • Absolute bioavailability of clarithromycin after oral administration in humans
    • Chu SY, Deaton R, and Cavanaugh J (1992) Absolute bioavailability of clarithromycin after oral administration in humans. Antimicrob Agents Chemother 36:1147-1150.
    • (1992) Antimicrob Agents Chemother , vol.36 , pp. 1147-1150
    • Chu, S.Y.1    Deaton, R.2    Cavanaugh, J.3
  • 7
    • 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
  • 8
    • 13244299150 scopus 로고    scopus 로고
    • Mechanism-based inactivation of CYP3A by HIV protease inhibitors
    • Ernest CS 2nd, Hall SD, and Jones DR (2005) Mechanism-based inactivation of CYP3A by HIV protease inhibitors. J Pharmacol Exp Ther 312:583-591.
    • (2005) J Pharmacol Exp Ther , vol.312 , pp. 583-591
    • Ernest II, C.S.1    Hall, S.D.2    Jones, D.R.3
  • 9
    • 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, 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
  • 10
    • 47949115175 scopus 로고    scopus 로고
    • A combined model for predicting CYP3A4 clinical net drug-drug interaction based on CYP3A4 inhibition, inactivation, and induction determined in vitro
    • Fahmi OA, Maurer TS, Kish M, Cardenas E, Boldt S, and Nettleton D (2008) A combined model for predicting CYP3A4 clinical net drug-drug interaction based on CYP3A4 inhibition, inactivation, and induction determined in vitro. Drug Metab Dispos 36:1698-1708.
    • (2008) Drug Metab Dispos , vol.36 , pp. 1698-1708
    • Fahmi, O.A.1    Maurer, T.S.2    Kish, M.3    Cardenas, E.4    Boldt, S.5    Nettleton, D.6
  • 11
    • 67349106390 scopus 로고    scopus 로고
    • Short-term clarithromycin administration impairs clearance and enhances pharmacodynamic effects of trazodone but not of zolpidem
    • Farkas D, Volak LP, Harmatz JS, von Moltke LL, Court MH, and Greenblatt DJ (2009) Short-term clarithromycin administration impairs clearance and enhances pharmacodynamic effects of trazodone but not of zolpidem. Clin Pharmacol Ther 85:644-650.
    • (2009) Clin Pharmacol Ther , vol.85 , pp. 644-650
    • Farkas, D.1    Volak, L.P.2    Harmatz, J.S.3    Von Moltke, L.L.4    Court, M.H.5    Greenblatt, D.J.6
  • 12
    • 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
  • 15
    • 0025999285 scopus 로고
    • In vitro forecasting of drugs which may interfere with the biotransformation of midazolam
    • Gascon MP and Dayer P (1991) In vitro forecasting of drugs which may interfere with the biotransformation of midazolam. Eur J Clin Pharmacol 41:573-578.
    • (1991) Eur J Clin Pharmacol , vol.41 , pp. 573-578
    • Gascon, M.P.1    Dayer, P.2
  • 20
    • 31444435037 scopus 로고    scopus 로고
    • Assessing the clinical significance of botanical supplementation on human cytochrome P450 3A activity: Comparison of a milk thistle and black cohosh product to rifampin and clarithromycin
    • Gurley B, Hubbard MA, Williams DK, Thaden J, Tong Y, Gentry WB, Breen P, Carrier DJ, and Cheboyina S (2006) Assessing the clinical significance of botanical supplementation on human cytochrome P450 3A activity: comparison of a milk thistle and black cohosh product to rifampin and clarithromycin. J Clin Pharmacol 46:201-213.
    • (2006) J Clin Pharmacol , vol.46 , pp. 201-213
    • Gurley, B.1    Hubbard, M.A.2    Williams, D.K.3    Thaden, J.4    Tong, Y.5    Gentry, W.B.6    Breen, P.7    Carrier, D.J.8    Cheboyina, S.9
  • 21
    • 37548998985 scopus 로고    scopus 로고
    • Supplementation with goldenseal (Hydrastis canadensis), but not kava kava (Piper methysticum), inhibits human CYP3A activity in vivo
    • Gurley BJ, Swain A, Hubbard MA, Hartsfield F, Thaden J, Williams DK, Gentry WB, and Tong Y (2008) Supplementation with goldenseal (Hydrastis canadensis), but not kava kava (Piper methysticum), inhibits human CYP3A activity in vivo. Clin Pharmacol Ther 83:61-69.
    • (2008) Clin Pharmacol Ther , vol.83 , pp. 61-69
    • Gurley, B.J.1    Swain, A.2    Hubbard, M.A.3    Hartsfield, F.4    Thaden, J.5    Williams, D.K.6    Gentry, W.B.7    Tong, Y.8
  • 22
    • 33645287695 scopus 로고    scopus 로고
    • The effect of ciprofloxacin and clarithromycin on sildenafil oral bioavailability in human volunteers
    • Hedaya MA, El-Afify DR, and El-Maghraby GM (2006) The effect of ciprofloxacin and clarithromycin on sildenafil oral bioavailability in human volunteers. Biopharm Drug Dispos 27:103-110.
    • (2006) Biopharm Drug Dispos , vol.27 , pp. 103-110
    • Hedaya, M.A.1    El-Afify, D.R.2    El-Maghraby, G.M.3
  • 23
    • 7044237064 scopus 로고    scopus 로고
    • Comparative pharmacokinetic interaction profiles of pravastatin, simvastatin, and atorvastatin when coadministered with cytochrome P450 inhibitors
    • Jacobson TA (2004) Comparative pharmacokinetic interaction profiles of pravastatin, simvastatin, and atorvastatin when coadministered with cytochrome P450 inhibitors. Am J Cardiol 94:1140-1146.
    • (2004) Am J Cardiol , vol.94 , pp. 1140-1146
    • Jacobson, T.A.1
  • 25
    • 0034089555 scopus 로고    scopus 로고
    • Prediction of in vivo interaction between triazolam and erythromycin based on in vitro studies using human liver microsomes and recombinant human CYP3A4
    • Kanamitsu S, Ito K, Green CE, Tyson CA, Shimada N, and Sugiyama Y (2000) Prediction of in vivo interaction between triazolam and erythromycin based on in vitro studies using human liver microsomes and recombinant human CYP3A4. Pharm Res 17:419-426.
    • (2000) Pharm Res , vol.17 , pp. 419-426
    • Kanamitsu, S.1    Ito, K.2    Green, C.E.3    Tyson, C.A.4    Shimada, N.5    Sugiyama, Y.6
  • 26
    • 0031670167 scopus 로고    scopus 로고
    • Erythromycin and verapamil considerably increase serum simvastatin and simvastatin acid concentrations
    • Kantola T, Kivistö KT, and Neuvonen PJ (1998) Erythromycin and verapamil considerably increase serum simvastatin and simvastatin acid concentrations. Clin Pharmacol Ther 64:177-182.
    • (1998) Clin Pharmacol Ther , vol.64 , pp. 177-182
    • Kantola, T.1    Kivistö, K.T.2    Neuvonen, P.J.3
  • 28
    • 0142040171 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic interactions of oral midazolam with ketoconazole, fluoxetine, fluvoxamine, and nefazodone
    • Lam YW, Alfaro CL, Ereshefsky L, and Miller M (2003) Pharmacokinetic and pharmacodynamic interactions of oral midazolam with ketoconazole, fluoxetine, fluvoxamine, and nefazodone. J Clin Pharmacol 43:1274-1282.
    • (2003) J Clin Pharmacol , vol.43 , pp. 1274-1282
    • Lam, Y.W.1    Alfaro, C.L.2    Ereshefsky, L.3    Miller, M.4
  • 29
    • 0028354849 scopus 로고
    • Pharmacokinetics and pharmacodynamics of a slow-release formulation of diltiazem after the administration of a single and repeated doses to healthy volunteers
    • Lefebvre M, Lacasse Y, Spénard J, Geadah D, Moisan R, Gossard D, Landriault H, Du Souich P, and Caillé G (1994) Pharmacokinetics and pharmacodynamics of a slow-release formulation of diltiazem after the administration of a single and repeated doses to healthy volunteers. Biopharm Drug Dispos 15:227-242.
    • (1994) Biopharm Drug Dispos , vol.15 , pp. 227-242
    • Lefebvre, M.1    Lacasse, Y.2    Spénard, J.3    Geadah, D.4    Moisan, R.5    Gossard, D.6    Landriault, H.7    Du Souich, P.8    Caillé, G.9
  • 30
    • 0033831197 scopus 로고    scopus 로고
    • An in vitro model for predicting in vivo inhibition of cytochrome P450 3A4 by metabolic intermediate complex formation
    • Mayhew BS, Jones DR, and Hall SD (2000) An in vitro model for predicting in vivo inhibition of cytochrome P450 3A4 by metabolic intermediate complex formation. Drug Metab Dispos 28:1031-1037.
    • (2000) Drug Metab Dispos , vol.28 , pp. 1031-1037
    • Mayhew, B.S.1    Jones, D.R.2    Hall, S.D.3
  • 32
    • 0036122644 scopus 로고    scopus 로고
    • The effects of steady-state erythromycin and azithromycin on the pharmacokinetics of sildenafil in healthy volunteers
    • Muirhead GJ, Faulkner S, Harness JA, and Taubel J (2002) The effects of steady-state erythromycin and azithromycin on the pharmacokinetics of sildenafil in healthy volunteers. Br J Clin Pharmacol 53 (Suppl 1):37S-43S.
    • (2002) Br J Clin Pharmacol , vol.53 , Issue.SUPPL. 1
    • Muirhead, G.J.1    Faulkner, S.2    Harness, J.A.3    Taubel, J.4
  • 34
    • 0021336416 scopus 로고
    • Pharmacokinetics and absolute bioavailability of diltiazem in humans
    • Ochs HR and Knüchel M (1984) Pharmacokinetics and absolute bioavailability of diltiazem in humans. Klin Wochenschr 62:303-306.
    • (1984) Klin Wochenschr , vol.62 , pp. 303-306
    • Ochs, H.R.1    Knüchel, M.2
  • 36
    • 34548049514 scopus 로고    scopus 로고
    • Effect of the treatment period with erythromycin on cytochrome P450 3A activity in humans
    • Okudaira T, Kotegawa T, Imai H, Tsutsumi K, Nakano S, and Ohashi K (2007) Effect of the treatment period with erythromycin on cytochrome P450 3A activity in humans. J Clin Pharmacol 47:871-876.
    • (2007) J Clin Pharmacol , vol.47 , pp. 871-876
    • Okudaira, T.1    Kotegawa, T.2    Imai, H.3    Tsutsumi, K.4    Nakano, S.5    Ohashi, K.6
  • 38
    • 0032807936 scopus 로고    scopus 로고
    • Effect of saquinavir on the pharmacokinetics and pharmacodynamics of oral and intravenous midazolam
    • Palkama VJ, Ahonen J, Neuvonen PJ, and Olkkola KT (1999) Effect of saquinavir on the pharmacokinetics and pharmacodynamics of oral and intravenous midazolam. Clin Pharmacol Ther 66:33-39.
    • (1999) Clin Pharmacol Ther , vol.66 , pp. 33-39
    • Palkama, V.J.1    Ahonen, J.2    Neuvonen, P.J.3    Olkkola, K.T.4
  • 40
    • 0032809187 scopus 로고    scopus 로고
    • Steady-state pharmacokinetics of high-dose diltiazem hydrochloride (Cardizem CD) administered once daily in healthy volunteers
    • Robbins-Weilert DK, Giesing DH, and Weir SJ (1999) Steady-state pharmacokinetics of high-dose diltiazem hydrochloride (Cardizem CD) administered once daily in healthy volunteers. Am J Ther 6:211-216.
    • (1999) Am J Ther , vol.6 , pp. 211-216
    • Robbins-Weilert, D.K.1    Giesing, D.H.2    Weir, S.J.3
  • 41
    • 0023713548 scopus 로고
    • Metabolic fate of TE-031 (A-56268). III. Absorption, distribution and excretion of 14C-TE-0341 in rats, mice and dogs
    • Suwa T, Yoshida H, Kohno Y, Yoshitumi S, and Ohta K (1988) Metabolic fate of TE-031 (A-56268). III. Absorption, distribution and excretion of 14C-TE-0341 in rats, mice and dogs. Chemotherapy 36:213-226.
    • (1988) Chemotherapy , vol.36 , pp. 213-226
    • Suwa, T.1    Yoshida, H.2    Kohno, Y.3    Yoshitumi, S.4    Ohta, K.5
  • 44
    • 0029925714 scopus 로고    scopus 로고
    • Diltiazem enhances the effects of triazolam by inhibiting its metabolism
    • Varhe A, Olkkola KT, and Neuvonen PJ (1996) Diltiazem enhances the effects of triazolam by inhibiting its metabolism. Clin Pharmacol Ther 59:369-375.
    • (1996) Clin Pharmacol Ther , vol.59 , pp. 369-375
    • Varhe, A.1    Olkkola, K.T.2    Neuvonen, P.J.3
  • 45
    • 76149134119 scopus 로고    scopus 로고
    • Age and sex effects on the recovery of CYP3A inhibition by clarithromycin
    • Wang YH, Gorski JC, Hamman MA, and Hall SD (2004a) Age and sex effects on the recovery of CYP3A inhibition by clarithromycin. Drug Metab Rev 36 (Suppl 1):287.
    • (2004) Drug Metab Rev , vol.36 , Issue.SUPPL. 1 , pp. 287
    • Wang, Y.H.1    Gorski, J.C.2    Hamman, M.A.3    Hall, S.D.4
  • 47
    • 0842282550 scopus 로고    scopus 로고
    • Prediction of cytochrome P450 3A inhibition by verapamil enantiomers and their metabolites
    • Wang YH, Jones DR, and Hall SD (2004b) Prediction of cytochrome P450 3A inhibition by verapamil enantiomers and their metabolites. Drug Metab Dispos 32:259-266.
    • (2004) Drug Metab Dispos , vol.32 , pp. 259-266
    • Wang, Y.H.1    Jones, D.R.2    Hall, S.D.3
  • 48
    • 0026719283 scopus 로고
    • A pharmacokinetic evaluation of the combined administration of triazolam and fluoxetine
    • Wright CE, Lasher-Sisson TA, Steenwyk RC, and Swanson CN (1992) A pharmacokinetic evaluation of the combined administration of triazolam and fluoxetine. Pharmacotherapy 12:103-106.
    • (1992) Pharmacotherapy , vol.12 , pp. 103-106
    • Wright, C.E.1    Lasher-Sisson, T.A.2    Steenwyk, R.C.3    Swanson, C.N.4
  • 49
    • 71049127036 scopus 로고    scopus 로고
    • Prediction of human drug-drug interactions from time-dependent inactivation of CYP3A4 in primary hepatocytes using a population-based simulator
    • Xu L, Chen Y, Pan Y, Skiles GL, and Shou M (2009) Prediction of human drug-drug interactions from time-dependent inactivation of CYP3A4 in primary hepatocytes using a population-based simulator. Drug Metab Dispos 37:2330-2339.
    • (2009) Drug Metab Dispos , vol.37 , pp. 2330-2339
    • Xu, L.1    Chen, Y.2    Pan, Y.3    Skiles, G.L.4    Shou, M.5
  • 50
    • 0035064595 scopus 로고    scopus 로고
    • Prediction of midazolam-CYP3A inhibitors interaction in the human liver from in vivo/in vitro absorption, distribution, and metabolism data
    • Yamano K, Yamamoto K, Katashima M, Kotaki H, Takedomi S, Matsuo H, Ohtani H, Sawada Y, and Iga T (2001) Prediction of midazolam-CYP3A inhibitors interaction in the human liver from in vivo/in vitro absorption, distribution, and metabolism data. Drug Metab Dispos 29:443-452.
    • (2001) Drug Metab Dispos , vol.29 , pp. 443-452
    • Yamano, K.1    Yamamoto, K.2    Katashima, M.3    Kotaki, H.4    Takedomi, S.5    Matsuo, H.6    Ohtani, H.7    Sawada, Y.8    Iga, T.9
  • 51
    • 24644441043 scopus 로고    scopus 로고
    • Kinetic values for mechanism-based enzyme inhibition: Assessing the bias introduced by the conventional experimental protocol
    • Yang J, Jamei M, Yeo KR, Tucker GT, and Rostami-Hodjegan A (2005) Kinetic values for mechanism-based enzyme inhibition: assessing the bias introduced by the conventional experimental protocol. Eur J Pharm Sci 26:334-340.
    • (2005) Eur J Pharm Sci , vol.26 , pp. 334-340
    • Yang, J.1    Jamei, M.2    Yeo, K.R.3    Tucker, G.T.4    Rostami-Hodjegan, A.5
  • 53
    • 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
  • 54
    • 0029984992 scopus 로고    scopus 로고
    • A kinetic and dynamic study of oral alprazolam with and without erythromycin in humans: In vivo evidence for the involvement of CYP3A4 in alprazolam metabolism
    • Yasui N, Otani K, Kaneko S, Ohkubo T, Osanai T, Sugawara K, Chiba K, and Ishizaki T (1996) A kinetic and dynamic study of oral alprazolam with and without erythromycin in humans: in vivo evidence for the involvement of CYP3A4 in alprazolam metabolism. Clin Pharmacol Ther 59:514-519.
    • (1996) Clin Pharmacol Ther , vol.59 , pp. 514-519
    • Yasui, N.1    Otani, K.2    Kaneko, S.3    Ohkubo, T.4    Osanai, T.5    Sugawara, K.6    Chiba, K.7    Ishizaki, T.8
  • 56
    • 0034854303 scopus 로고    scopus 로고
    • Inhibitory effects of verapamil and diltiazem on simvastatin metabolism in human liver microsomes
    • Yeo KR and Yeo WW (2001) Inhibitory effects of verapamil and diltiazem on simvastatin metabolism in human liver microsomes. Br J Clin Pharmacol 51:461-470.
    • (2001) Br J Clin Pharmacol , vol.51 , pp. 461-470
    • Yeo, K.R.1    Yeo, W.W.2
  • 57
    • 67650812077 scopus 로고    scopus 로고
    • Semiphysiologically based pharmacokinetic models for the inhibition of midazolam clearance by diltiazem and its major metabolite
    • Zhang X, Quinney SK, Gorski JC, Jones DR, and Hall SD (2009) Semiphysiologically based pharmacokinetic models for the inhibition of midazolam clearance by diltiazem and its major metabolite. Drug Metab Dispos 37:1587-1597.
    • (2009) Drug Metab Dispos , vol.37 , pp. 1587-1597
    • Zhang, X.1    Quinney, S.K.2    Gorski, J.C.3    Jones, D.R.4    Hall, S.D.5
  • 58
    • 18844445670 scopus 로고    scopus 로고
    • Evaluation of time-dependent inactivation of CYP3A in cryopreserved human hepatocytes
    • Zhao P, Kunze KL, and Lee CA (2005) Evaluation of time-dependent inactivation of CYP3A in cryopreserved human hepatocytes. Drug Metab Dispos 33:853-861.
    • (2005) Drug Metab Dispos , vol.33 , pp. 853-861
    • Zhao, P.1    Kunze, K.L.2    Lee, C.A.3
  • 59
    • 34247356616 scopus 로고    scopus 로고
    • Sequential metabolism is responsible for diltiazem-induced time-dependent loss of CYP3A
    • Zhao P, Lee CA, and Kunze KL (2007) Sequential metabolism is responsible for diltiazem-induced time-dependent loss of CYP3A. Drug Metab Dispos 35:704-712.
    • (2007) Drug Metab Dispos , vol.35 , pp. 704-712
    • Zhao, P.1    Lee, C.A.2    Kunze, K.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.