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Volumn 97, Issue 2, 2015, Pages 177-185

Predicting drug-drug interactions involving multiple mechanisms using physiologically based pharmacokinetic modeling: A case study with ruxolitinib

Author keywords

[No Author keywords available]

Indexed keywords

DIGOXIN; ERYTHROMYCIN; FLUCONAZOLE; KETOCONAZOLE; RIFAMPICIN; RUXOLITINIB; CYTOCHROME P450 3A INDUCER; CYTOCHROME P450 3A INHIBITOR; PYRAZOLE DERIVATIVE;

EID: 84927172074     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.30     Document Type: Article
Times cited : (25)

References (28)
  • 1
    • 77949351406 scopus 로고    scopus 로고
    • Drug interactions evaluation: An integrated part of risk assessment of therapeutics
    • Zhang, L., Reynolds, K.S., Zhao, P. & Huang, S.M. Drug interactions evaluation: An integrated part of risk assessment of therapeutics. Toxicol. Appl. Pharmacol. 243, 134-145 (2010).
    • (2010) Toxicol. Appl. Pharmacol. , vol.243 , pp. 134-145
    • Zhang, L.1    Reynolds, K.S.2    Zhao, P.3    Huang, S.M.4
  • 3
  • 4
    • 84893740148 scopus 로고    scopus 로고
    • Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug
    • Vieira, M.L. et al. Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug. Clin. Pharmacol. Ther. 95, 189-198 (2014).
    • (2014) Clin. Pharmacol. Ther. , vol.95 , pp. 189-198
    • Vieira, M.L.1
  • 5
    • 84893796916 scopus 로고    scopus 로고
    • In vitro prediction of clinical drug interactions with CYP3A substrates: We are not there yet
    • Greenblatt, D.J. In vitro prediction of clinical drug interactions with CYP3A substrates: We are not there yet. Clin. Pharmacol. Ther. 95, 133-135 (2014).
    • (2014) Clin. Pharmacol. Ther. , vol.95 , pp. 133-135
    • Greenblatt, D.J.1
  • 6
    • 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, O.A., Maurer, T.S., Kish, M., Cardenas, E., Boldt, S. & Nettleton, D. 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).
    • (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
  • 7
    • 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, O.A. et al. 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).
    • (2009) Drug Metab. Dispos. , vol.37 , pp. 1658-1666
    • Fahmi, O.A.1
  • 8
    • 35648968125 scopus 로고    scopus 로고
    • Comparison of different approaches to predict metabolic drug-drug interactions
    • Einolf, H.J. Comparison of different approaches to predict metabolic drug-drug interactions. Xenobiotica 37, 1257-1294 (2007).
    • (2007) Xenobiotica , vol.37 , pp. 1257-1294
    • Einolf, H.J.1
  • 9
    • 78650016675 scopus 로고    scopus 로고
    • Assessment of algorithms for predicting drug-drug interactions via inhibition mechanisms: Comparison of dynamic and statistic models
    • Guest, E.J., Rowland-Yeo, K., Rostami-Hodjegan, A., Tucker, G.T., Houston, J.B. & Galetin, A. Assessment of algorithms for predicting drug-drug interactions via inhibition mechanisms: Comparison of dynamic and statistic models. Br. J. Clin. Pharmacol. 71, 72-87 (2010).
    • (2010) Br. J. Clin. Pharmacol. , vol.71 , pp. 72-87
    • Guest, E.J.1    Rowland-Yeo, K.2    Rostami-Hodjegan, A.3    Tucker, G.T.4    Houston, J.B.5    Galetin, A.6
  • 10
    • 84861806284 scopus 로고    scopus 로고
    • The effect of CYP3A4 inhibition or induction on the pharmacokinetics and pharmacodynamics of orally administered ruxolitinib (INCB018424 phosphate) in healthy volunteers
    • Shi, J.G. et al. The effect of CYP3A4 inhibition or induction on the pharmacokinetics and pharmacodynamics of orally administered ruxolitinib (INCB018424 phosphate) in healthy volunteers. J. Clin. Pharmacol. 52, 809-818 (2012).
    • (2012) J. Clin. Pharmacol. , vol.52 , pp. 809-818
    • Shi, J.G.1
  • 11
    • 78049412594 scopus 로고    scopus 로고
    • Metabolism, excretion and pharmacokinetics following an oral dose of 14C-INCB018424 to healthy human subjects
    • Shilling A.D. et al. Metabolism, excretion and pharmacokinetics following an oral dose of 14C-INCB018424 to healthy human subjects. Drug Metab. Dispos. 38, 2023-2031 (2010).
    • (2010) Drug Metab. Dispos. , vol.38 , pp. 2023-2031
    • Shilling, A.D.1
  • 12
    • 80053014000 scopus 로고    scopus 로고
    • The pharmacokinetics, pharmacodynamics and safety of orally dosed INCB018424 phosphate in healthy volunteers
    • Shi, J.G. et al. The pharmacokinetics, pharmacodynamics and safety of orally dosed INCB018424 phosphate in healthy volunteers. J. Clin. Pharmacol. 51, 1644-1654 (2011).
    • (2011) J. Clin. Pharmacol. , vol.51 , pp. 1644-1654
    • Shi, J.G.1
  • 13
    • 84880321287 scopus 로고    scopus 로고
    • Population pharmacokinetic analysis of orally-administered ruxolitinib (INCB018424 phosphate) in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or postessential thrombocythemia myelofibrosis (PET MF)
    • Chen, X., Williams, W.V., Sandor, V., & Yeleswaram, S. Population pharmacokinetic analysis of orally-administered ruxolitinib (INCB018424 phosphate) in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or postessential thrombocythemia myelofibrosis (PET MF). J. Clin. Pharmacol. 53, 721-730 (2013).
    • (2013) J. Clin. Pharmacol. , vol.53 , pp. 721-730
    • Chen, X.1    Williams, W.V.2    Sandor, V.3    Yeleswaram, S.4
  • 14
    • 0015517794 scopus 로고
    • Absorption of orally given digoxin preparations
    • Huffman, D.H. & Azarnoff, D.L. Absorption of orally given digoxin preparations. J. Am. Med. Assoc. 222, 957-960 (1972).
    • (1972) J. Am. Med. Assoc. , vol.222 , pp. 957-960
    • Huffman, D.H.1    Azarnoff, D.L.2
  • 15
    • 84895520896 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic modeling of CYP3A4 induction by rifampicin in human: Influence of time between substrate and inducer administration
    • Baneyx, G., Parrot N., Meille, C., Iliadis, A. & Lave T. Physiologically based pharmacokinetic modeling of CYP3A4 induction by rifampicin in human: Influence of time between substrate and inducer administration. Eur. J. Pharm. Sci. 56C, 1-15 (2014).
    • (2014) Eur. J. Pharm. Sci. , vol.56 C , pp. 1-15
    • Baneyx, G.1    Parrot, N.2    Meille, C.3    Iliadis, A.4    Lave, T.5
  • 16
    • 84929181792 scopus 로고    scopus 로고
    • [U.S. prescribing information].
    • Fluconazole (Diflucan) [U.S. prescribing information]. http://www.accessdata.fda.gov/drugsat.fda-docs/label/2011/019949s051lbl.
    • Fluconazole (Diflucan)
  • 17
    • 84892463284 scopus 로고    scopus 로고
    • Evaluation of the effect of fluconazole and ketoconazole on the pharmacokinetics of tofacitinib in healthy adult subjects
    • Gupta, P. et al. Evaluation of the effect of fluconazole and ketoconazole on the pharmacokinetics of tofacitinib in healthy adult subjects. Clin. Pharmacol. Drug Dev. 3, 72-77 (2013).
    • (2013) Clin. Pharmacol. Drug Dev. , vol.3 , pp. 72-77
    • Gupta, P.1
  • 18
    • 84990249273 scopus 로고    scopus 로고
    • The relevance of assessment of intestinal P-gp inhibition using digoxin as an in vivo probe substrate
    • Shi, J.G., Zhang, Y. & Yeleswaram, S. The relevance of assessment of intestinal P-gp inhibition using digoxin as an in vivo probe substrate. Nat. Rev. Drug Discov. 9, 215-236 (2010).
    • (2010) Nat. Rev. Drug Discov. , vol.9 , pp. 215-236
    • Shi, J.G.1    Zhang, Y.2    Yeleswaram, S.3
  • 19
    • 36249014207 scopus 로고    scopus 로고
    • Role of p-glycoprotein inhibition for drug interactions: Evidence from in vitro and pharmacoepidemiological studies
    • Eberl, S. et al. Role of p-glycoprotein inhibition for drug interactions: Evidence from in vitro and pharmacoepidemiological studies. Clin. Pharmacokinet. 46, 1039-1049 (2007).
    • (2007) Clin. Pharmacokinet. , vol.46 , pp. 1039-1049
    • Eberl, S.1
  • 20
    • 0036786390 scopus 로고    scopus 로고
    • The effect of erythromycin and clarithromycin on the pharmacokinetics of intravenous digoxin in healthy volunteers
    • Tsutsumi, K. et al. The effect of erythromycin and clarithromycin on the pharmacokinetics of intravenous digoxin in healthy volunteers. J. Clin. Pharmacol. 42, 1159-1164 (2002).
    • (2002) J. Clin. Pharmacol. , vol.42 , pp. 1159-1164
    • Tsutsumi, K.1
  • 21
    • 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
  • 22
    • 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
  • 23
    • 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
  • 24
    • 84862299668 scopus 로고    scopus 로고
    • World Health Organization, International Programme on Chemical Safety, Geneva, Switzerland.
    • International Programme on Chemical Safety (IPCS), 2010. Characterization and application of physiologically based pharmacokinetic models in risk assessment, World Health Organization, International Programme on Chemical Safety, Geneva, Switzerland. http://www. who.int/ipcs/methods/harmonization/areas/pbpk-models.pdf (2010).
    • (2010) Characterization and Application of Physiologically Based Pharmacokinetic Models in Risk Assessment
  • 25
    • 84929157365 scopus 로고    scopus 로고
    • Combining the "bottom-up" and "top-down" approaches in pharmacokinetic modeling: Fitting PBPK models to observed clinical data
    • in press
    • Tsamandouras, N., Rostami-Hodjegan, A. & Aarons, L. Aarons. Combining the "bottom-up" and "top-down" approaches in pharmacokinetic modeling: Fitting PBPK models to observed clinical data. Br. J. Clin. Pharmacol. (in press).
    • Br. J. Clin. Pharmacol.
    • Tsamandouras, N.1    Rostami-Hodjegan, A.2    Aarons, A.L.3
  • 26
    • 0035478779 scopus 로고    scopus 로고
    • Predicting the impact of physiological and biochemical processes on oral drug bioavailability
    • Agoram, B., Woltosz, W.S. & Bolger, W.S. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv. Drug Deliv. Rev. 50 (suppl. 1), S41-S67.
    • Adv. Drug Deliv. Rev. , vol.50 , pp. 41-67
    • Agoram, B.1    Woltosz, W.S.2    Bolger, W.S.3
  • 27
    • 0028237729 scopus 로고
    • Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: Studies with liver microsomes of 30 Japanese and 30 Caucasians
    • Shimada, T., Yamazaki, H., Mimura, M., Inui, Y. & Guengerich, F.P. Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: Studies with liver microsomes of 30 Japanese and 30 Caucasians. J. Pharmacol. Exp. Ther. 270, 414-423 (1994).
    • (1994) J. Pharmacol. Exp. Ther. , vol.270 , pp. 414-423
    • Shimada, T.1    Yamazaki, H.2    Mimura, M.3    Inui, Y.4    Guengerich, F.P.5
  • 28
    • 0032924934 scopus 로고    scopus 로고
    • Cytochrome P-450 3A4: Regulation and role in drug metabolism
    • Guengerich, F.P. Cytochrome P-450 3A4: Regulation and role in drug metabolism. Annu. Rev. Pharmacol. Toxicol. 39, 1-17 (1999).
    • (1999) Annu. Rev. Pharmacol. Toxicol. , vol.39 , pp. 1-17
    • Guengerich, F.P.1


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