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Volumn 22, Issue 2, 2009, Pages 257-262

Safety assessment of drug metabolites: Implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450s

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450; DRUG METABOLITE;

EID: 62249100639     PISSN: 0893228X     EISSN: 15205010     Source Type: Journal    
DOI: 10.1021/tx8004373     Document Type: Review
Times cited : (29)

References (38)
  • 2
    • 33845734598 scopus 로고    scopus 로고
    • A regulatory perspective on issues and approaches in characterizing human metabolites
    • Davis-Bruno, K. L., and Atrakchi, A. (2006) A regulatory perspective on issues and approaches in characterizing human metabolites. Chem. Res. Toxicol. 19, 1561-1563.
    • (2006) Chem. Res. Toxicol , vol.19 , pp. 1561-1563
    • Davis-Bruno, K.L.1    Atrakchi, A.2
  • 3
    • 33845792941 scopus 로고    scopus 로고
    • Safety assessment of stable drug metabolites
    • Guengerich, F. P. (2006) Safety assessment of stable drug metabolites. Chem. Res. Toxicol. 19, 1559-1560.
    • (2006) Chem. Res. Toxicol , vol.19 , pp. 1559-1560
    • Guengerich, F.P.1
  • 5
    • 33845769325 scopus 로고    scopus 로고
    • Safety assessment of drug metabolites: Characterization of chemically stable metabolites
    • Humphreys, W. G., and Under, S. E. (2006) Safety assessment of drug metabolites: characterization of chemically stable metabolites. Chem. Res. Toxicol. 19, 1564-1569.
    • (2006) Chem. Res. Toxicol , vol.19 , pp. 1564-1569
    • Humphreys, W.G.1    Under, S.E.2
  • 6
    • 47649088457 scopus 로고    scopus 로고
    • Unique/major human metabolites: Why, how, and when to test for safety in animals
    • Luffer-Atlas, D. (2008) Unique/major human metabolites: why, how, and when to test for safety in animals. Drug Metab. Dispos. 40, 447-463.
    • (2008) Drug Metab. Dispos , vol.40 , pp. 447-463
    • Luffer-Atlas, D.1
  • 7
    • 24944563781 scopus 로고    scopus 로고
    • Seeing through the MIST: Abundance versus percentage. Commentary on metabolites in safety testing
    • Smith, D. A., and Obach, R. S. (2005) Seeing through the MIST: abundance versus percentage. Commentary on metabolites in safety testing. Drug Metab. Dispos. 33, 1409-1417.
    • (2005) Drug Metab. Dispos , vol.33 , pp. 1409-1417
    • Smith, D.A.1    Obach, R.S.2
  • 8
    • 33845748169 scopus 로고    scopus 로고
    • Metabolites and safety: What are the concerns, and how should we address them?
    • Smith, D. A., and Obach, R. S. (2006) Metabolites and safety: What are the concerns, and how should we address them? Chem. Res. Toxicol. 19, 1570-1579.
    • (2006) Chem. Res. Toxicol , vol.19 , pp. 1570-1579
    • Smith, D.A.1    Obach, R.S.2
  • 9
    • 62249108055 scopus 로고    scopus 로고
    • Smith, D. A., Obach, R. S., Wiliams, D. P., and Park, B. K. (2008) Clearing the MIST (metabolites in safety testing) of time: The impact of duration of administration on drug metabolite toxicity. Chem.-Biol. Interact. [Online early access]. Published Online, September 26, 2008.
    • Smith, D. A., Obach, R. S., Wiliams, D. P., and Park, B. K. (2008) Clearing the MIST (metabolites in safety testing) of time: The impact of duration of administration on drug metabolite toxicity. Chem.-Biol. Interact. [Online early access]. Published Online, September 26, 2008.
  • 11
    • 33751249069 scopus 로고    scopus 로고
    • Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites
    • Preuksaritanont, T., Jiunn, H. L., and Baillie, T. A. (2006) Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites. Toxicol. Appl. Pharmacol. 217, 143-152.
    • (2006) Toxicol. Appl. Pharmacol , vol.217 , pp. 143-152
    • Preuksaritanont, T.1    Jiunn, H.L.2    Baillie, T.A.3
  • 12
    • 33846461683 scopus 로고    scopus 로고
    • The pregnane X receptor gene-humanized mouse: A model for investigating drug-drug interactions mediated by cytochromes P450 3A
    • Ma, X., Shah, Y., Cheung, C., Guo, G. L., Feigenbaum, L., Krausz, K. W., Idle, J. R., and Gonzalez, F. J. (2007) The pregnane X receptor gene-humanized mouse: a model for investigating drug-drug interactions mediated by cytochromes P450 3A. Drug Metab. Dispos. 35, 194-200.
    • (2007) Drug Metab. Dispos , vol.35 , pp. 194-200
    • Ma, X.1    Shah, Y.2    Cheung, C.3    Guo, G.L.4    Feigenbaum, L.5    Krausz, K.W.6    Idle, J.R.7    Gonzalez, F.J.8
  • 13
    • 51349112400 scopus 로고    scopus 로고
    • A novel panel of mouse models to evaluate the role of human pregnane X receptor and constitutive androstane receptor in drug response
    • Scheer, N., Ross, J., Rode, A., Zevnik, B., Niehaves, S., Faust, N., and Wolf, C. R. (2008) A novel panel of mouse models to evaluate the role of human pregnane X receptor and constitutive androstane receptor in drug response. J. Clin. Invest. 118, 3228-3229.
    • (2008) J. Clin. Invest , vol.118 , pp. 3228-3229
    • Scheer, N.1    Ross, J.2    Rode, A.3    Zevnik, B.4    Niehaves, S.5    Faust, N.6    Wolf, C.R.7
  • 15
    • 57349179929 scopus 로고    scopus 로고
    • Ma, X., Cheung, C., Krausz, K. W., Shah, Y. M., Wang, T., Idle, J. R., and Gonzalez, F. J. (2008) A double transgenic mouse model expressing human pregnane X receptor and cytochrome P450 3A4. Drug Metab. Dispos. [Online early access]. Published Online, September 17, 2008.
    • Ma, X., Cheung, C., Krausz, K. W., Shah, Y. M., Wang, T., Idle, J. R., and Gonzalez, F. J. (2008) A double transgenic mouse model expressing human pregnane X receptor and cytochrome P450 3A4. Drug Metab. Dispos. [Online early access]. Published Online, September 17, 2008.
  • 16
    • 0036548404 scopus 로고    scopus 로고
    • Cytochromes P450 and experimental models of drug metabolism
    • Zuber, R., Anzenbacherova, E., and Anzenbacher, P. (2002) Cytochromes P450 and experimental models of drug metabolism. J. Cell. Mol. Med. 6, 189-198.
    • (2002) J. Cell. Mol. Med , vol.6 , pp. 189-198
    • Zuber, R.1    Anzenbacherova, E.2    Anzenbacher, P.3
  • 19
    • 22544453632 scopus 로고    scopus 로고
    • Theophylline pharmacokinetics: Comparison of Cyp1a1(-/-) and Cyp1a2(-/-) knockout mice, humanized hCYP1A1_1A2 knock-in mice lacking wither the mouse Cyp1a1 or Cyp1a2 gene, and Cyp1(+/+) wild-type mice
    • Derkenne, S. D., Curran, C. P., Shertzer, H, G., Dalton, T. P., Dragin, N., and Nebert, D. W. (2005) Theophylline pharmacokinetics: comparison of Cyp1a1(-/-) and Cyp1a2(-/-) knockout mice, humanized hCYP1A1_1A2 knock-in mice lacking wither the mouse Cyp1a1 or Cyp1a2 gene, and Cyp1(+/+) wild-type mice. Pharmacogenet. Genomes 15, 503-511.
    • (2005) Pharmacogenet. Genomes , vol.15 , pp. 503-511
    • Derkenne, S.D.1    Curran, C.P.2    Shertzer, H.G.3    Dalton, T.P.4    Dragin, N.5    Nebert, D.W.6
  • 20
    • 13444252325 scopus 로고    scopus 로고
    • Toward the evaluation of function in genetic variability: Characterizing human SNPs and establishing BAC-transgenic mice carrying the CYP1A1_CYP1A2 locus
    • Jiang, Z. W., Dalton, T. P., Tin, L., Wang, B., Tsuneoka, Y., Shertzer, H. G., Deka, R., and Nebert, D. W. (2005) Toward the evaluation of function in genetic variability: characterizing human SNPs and establishing BAC-transgenic mice carrying the CYP1A1_CYP1A2 locus. Hum. Mutat. 25, 196-206.
    • (2005) Hum. Mutat , vol.25 , pp. 196-206
    • Jiang, Z.W.1    Dalton, T.P.2    Tin, L.3    Wang, B.4    Tsuneoka, Y.5    Shertzer, H.G.6    Deka, R.7    Nebert, D.W.8
  • 22
  • 24
    • 0037403715 scopus 로고    scopus 로고
    • Expression of the human CYP3A4 gene in the small intestine of transgenic mice: In vitro metabolism and pharmacokinetics of midazolam
    • Granvil, C. P., Yu, A.-M., Elizondo, G., Akiyama, T. E., Cheung, C., Feigenbaum, L., Krausz, K. W., and Gonzalez, F. J. (2003) Expression of the human CYP3A4 gene in the small intestine of transgenic mice: in vitro metabolism and pharmacokinetics of midazolam. Drug Metab. Dispos. 31, 548-558.
    • (2003) Drug Metab. Dispos , vol.31 , pp. 548-558
    • Granvil, C.P.1    Yu, A.-M.2    Elizondo, G.3    Akiyama, T.E.4    Cheung, C.5    Feigenbaum, L.6    Krausz, K.W.7    Gonzalez, F.J.8
  • 28
    • 38749088304 scopus 로고    scopus 로고
    • Cytochrome P450 expression and regulation in CYP3A4/CYP2D6 double transgenic humanized mice
    • Felmlee, M. A., Lon, H.-K., Gonzalez, F. J., and Yu, A.-M. (2008) Cytochrome P450 expression and regulation in CYP3A4/CYP2D6 double transgenic humanized mice. Drug Metab. Dispos. 36, 435-441.
    • (2008) Drug Metab. Dispos , vol.36 , pp. 435-441
    • Felmlee, M.A.1    Lon, H.-K.2    Gonzalez, F.J.3    Yu, A.-M.4
  • 29
    • 33144459032 scopus 로고    scopus 로고
    • Cytochrome P450 and xenobiotic receptor humanized mice
    • Gonzalez, F. J., and Yu, A.-M. (2006) Cytochrome P450 and xenobiotic receptor humanized mice. Annu. Rev. Pharmacol. Toxicol. 46, 41-64.
    • (2006) Annu. Rev. Pharmacol. Toxicol , vol.46 , pp. 41-64
    • Gonzalez, F.J.1    Yu, A.-M.2
  • 30
    • 47749137002 scopus 로고    scopus 로고
    • Applications and limitations of genetically modified mouse models in drug discovery and development
    • Lin, J. H. (2008) Applications and limitations of genetically modified mouse models in drug discovery and development. Current Drug Metab. 9, 419-438.
    • (2008) Current Drug Metab , vol.9 , pp. 419-438
    • Lin, J.H.1
  • 31
    • 43949122957 scopus 로고    scopus 로고
    • Mice as clinically relevant models for the study of cytochrome P450-dependent metabolism
    • Muruganandan, S., and Sinal, C. J. (2008) Mice as clinically relevant models for the study of cytochrome P450-dependent metabolism. Clin. Pharm. Ther. 83, 818-827.
    • (2008) Clin. Pharm. Ther , vol.83 , pp. 818-827
    • Muruganandan, S.1    Sinal, C.J.2
  • 32
    • 54349128898 scopus 로고    scopus 로고
    • Humanized mouse lines and their application for prediction of human drug metabolism and lexicological risk assessment
    • Cheung, C., and Gonzalez, F. J. (2008) Humanized mouse lines and their application for prediction of human drug metabolism and lexicological risk assessment. J. Pharmacol. Exp. Ther. 327, 288-299.
    • (2008) J. Pharmacol. Exp. Ther , vol.327 , pp. 288-299
    • Cheung, C.1    Gonzalez, F.J.2
  • 34
    • 41549139685 scopus 로고    scopus 로고
    • High through-put, accurate mass liquid chromotagraphy/tandem mass spectrometry on a quadrupole time-of-flight system as a "first-line" approach for metabolite identification studies
    • Tiller, P. R., Yu, S., Castro-Perez, J., Fillgrove, K. L., and Baillie, T. A. (2008) High through-put, accurate mass liquid chromotagraphy/tandem mass spectrometry on a quadrupole time-of-flight system as a "first-line" approach for metabolite identification studies. Rapid Commun. Mass Spectrom. 22, 1053-1061.
    • (2008) Rapid Commun. Mass Spectrom , vol.22 , pp. 1053-1061
    • Tiller, P.R.1    Yu, S.2    Castro-Perez, J.3    Fillgrove, K.L.4    Baillie, T.A.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.