메뉴 건너뛰기




Volumn 87, Issue 3, 2010, Pages 345-350

Metabolites in safety testing: MIST for the clinical pharmacologist

Author keywords

[No Author keywords available]

Indexed keywords

BENZODIAZEPINE DERIVATIVE; CARBAMAZEPINE; DRUG METABOLITE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; N ACETYL 1,4 BENZOQUINONE IMINE; NOMIFENSINE; OPIATE DERIVATIVE; PARACETAMOL; PHENYTOIN; SELECTIVE ESTROGEN RECEPTOR MODULATOR; TERFENADINE;

EID: 77149125562     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.283     Document Type: Review
Times cited : (38)

References (30)
  • 1
    • 0005248386 scopus 로고    scopus 로고
    • Guidance for Industry: Safety Testing of Drug Metabolites
    • US Food and Drug administration. Guidance for Industry: Safety Testing of Drug Metabolites (2008).
    • (2008) US Food and Drug Administration
  • 3
    • 18644385994 scopus 로고    scopus 로고
    • Drug metabolites in safety testing
    • Baillie, T.a. et al. Drug metabolites in safety testing. Toxicol. Appl. Pharmacol. 182,188-196(2002).
    • (2002) Toxicol. Appl. Pharmacol. , vol.182 , pp. 188-196
    • Baillie, T.A.1
  • 5
    • 33751200851 scopus 로고    scopus 로고
    • Response to letter to the editor
    • Baillie,T.A. et al. Response to Letter to the Editor. Toxicol. Appl. Pharmacol. 190, 93-94(2003).
    • (2003) Toxicol. Appl. Pharmacol. , vol.190 , pp. 93-94
    • Bailliet, A.1
  • 6
    • 2542465496 scopus 로고    scopus 로고
    • Guidance for Industry: Safety Testing of Drug Metabolites (Draft Guidance)
    • Food and Drug administration. Guidance for Industry: Safety Testing of Drug Metabolites (Draft Guidance) (2005)
    • (2005) Food and Drug Administration
  • 7
    • 33751249069 scopus 로고    scopus 로고
    • Complicating factors in safety testing of drug metabolites: Kinetic diferences between generated and preformed metabolites
    • Prueksaritanont,T., Lin, J.H.&Baillie,T.A. Complicating factors in safety testing of drug metabolites: kinetic diferences between generated and preformed metabolites. Toxicol. Appl. Pharmacol. 217,143-152 (2006).
    • (2006) Toxicol. Appl. Pharmacol. , vol.217 , pp. 143-152
    • Prueksaritanont, T.1    Lin, J.H.2    Bailliet, A.3
  • 8
    • 24944563781 scopus 로고    scopus 로고
    • Seeing through the mist: Abundance versus percentage. commentary on metabolites in safety testing
    • Smith, Da. & Obach, R.S. Seeing through the mist: abundance versus percentage. commentary on metabolites in safety testing. Drug Metab. Dispos. 33,1409-1417 (2005).
    • (2005) Drug Metab. Dispos. , vol.33 , pp. 1409-1417
    • Smith, D.A.1    Obach, R.S.2
  • 9
    • 33845748169 scopus 로고    scopus 로고
    • Metabolites and safety: What are the concerns, and how should we address them?
    • Smith, Da. & Obach, R.S. Metabolites and safety: What are the concerns, and how should we address them? Chem. Res. Toxicol. 19,1570-1579 (2006).
    • (2006) Chem. Res. Toxicol. , vol.19 , pp. 1570-1579
    • Smith, D.A.1    Obach, R.S.2
  • 10
    • 67650996775 scopus 로고    scopus 로고
    • Interpretation and considerations on the safety evaluation of human drug metabolites
    • Atrakchi, A.H. Interpretation and considerations on the safety evaluation of human drug metabolites. Chem. Res. Toxicol. 22,1217-1220 (2009).
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 1217-1220
    • Atrakchi, A.H.1
  • 11
    • 62249135160 scopus 로고    scopus 로고
    • Approaches to the assessment of stable and chemically reactive drug metabolites in early Clinical trials
    • Baillie, T.A. approaches to the assessment of stable and chemically reactive drug metabolites in early Clinical trials. Chem. Res. Toxicol. 22, 263-266 (2009).
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 263-266
    • Baillie, T.A.1
  • 12
    • 62249142787 scopus 로고    scopus 로고
    • Which human metabolites havewe MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development
    • Leclercq, L, Cuyckens, F., Mannens, G.S., de Vries, R., Timmerman, P. & Evans, D.C. Which human metabolites havewe MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development. Chem. Res. Toxicol. 22, 280-293 (2009).
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 280-293
    • Leclercq, L.1    Cuyckens, F.2    Mannens, G.S.3    De Vries, R.4    Timmerman, P.5    Evans, D.C.6
  • 13
    • 0037422456 scopus 로고    scopus 로고
    • Acyl glucuronide reactivity in perspective: Biological consequences
    • Bailey, M.J. & Dickinson, R.G. Acyl glucuronide reactivity in perspective: biological consequences. Chem. Biol. Interact. 145,117-137 (2003).
    • (2003) Chem. Biol. Interact. , vol.145 , pp. 117-137
    • Bailey, M.J.1    Dickinson, R.G.2
  • 14
    • 0037306174 scopus 로고    scopus 로고
    • Acyl glucuronide drug metabolites: Toxicological and analytical implications
    • Shipkova, M., armstrong, V.W, Oellerich, M. & Wieland, E. Acyl glucuronide drug metabolites: toxicological and analytical implications. Ther. Drug Monit. 25,1-16(2003).
    • (2003) Ther. Drug Monit. , vol.25 , pp. 1-16
    • Shipkova, M.1    Armstrong, V.W.2    Oellerich, M.3    Wieland, E.4
  • 15
    • 0031719374 scopus 로고    scopus 로고
    • Role of drug disposition in drug hypersensitivity: A chemical, molecular, and Clinical perspective
    • Park, B.K., Pirmohamed, M.&Kitteringham, N.R. Role of drug disposition in drug hypersensitivity: a chemical, molecular, and Clinical perspective. Chem. Res. Toxicol. 11,969-988 (1998).
    • (1998) Chem. Res. Toxicol. , vol.11 , pp. 969-988
    • Park, B.K.1    Pirmohamed, M.2    Kitteringham, N.R.3
  • 16
    • 34047266790 scopus 로고    scopus 로고
    • Applying mechanisms of chemical toxicity to predict drug safety
    • Guengerich, F.P.&MacDonald,J.S. Applying mechanisms of chemical toxicity to predict drug safety. Chem. Res. Toxicol. 20,344-369 (2007)
    • (2007) Chem. Res. Toxicol. , vol.20 , pp. 344-369
    • Guengerich, F.P.1    MacDonald, J.S.2
  • 17
    • 34548805504 scopus 로고    scopus 로고
    • Mechanism-based inactivation of cytochrome P450 enzymes: Chemical mechanisms, structure-activity relationships and relationship to Clinical drug-drug interactions and idiosyncratic adverse drug reactions
    • Kalgutkar, A.S., Obach, R.S. & Maurer, T.S. Mechanism-based inactivation of cytochrome P450 enzymes: chemical mechanisms, structure-activity relationships and relationship to Clinical drug-drug interactions and idiosyncratic adverse drug reactions. Curr. Drug Metab. 8,407-447 (2007).
    • (2007) Curr. Drug Metab. , vol.8 , pp. 407-447
    • Kalgutkar, A.S.1    Obach, R.S.2    Maurer, T.S.3
  • 19
    • 0023124537 scopus 로고
    • Dose-dependent pharmacokinetics of acetaminophen: Evidence of glutathione depletion in humans
    • Slattery, J.T., Wilson, J.M., Kalhorn,T.F. & Nelson, S.D. Dose-dependent pharmacokinetics of acetaminophen: evidence of glutathione depletion in humans. Clin. Pharmacol. Ther. 41,413-418 (1987).
    • (1987) Clin. Pharmacol. Ther. , vol.41 , pp. 413-418
    • Slattery, J.T.1    Wilson, J.M.2    Kalhornt, F.3    Nelson, S.D.4
  • 20
    • 19944399431 scopus 로고    scopus 로고
    • A comprehensive listing of bioactivation pathways of organic functional groups
    • Kalgutkar, a.S. et al. A comprehensive listing of bioactivation pathways of organic functional groups. Curr. Drug Metab. 6; 161-225 (2005).
    • (2005) Curr. Drug Metab. , vol.6 , pp. 61-225
    • Kalgutkar, A.S.1
  • 21
    • 34248572197 scopus 로고    scopus 로고
    • MSE with mass defect fltering for in vitro and in vivo metabolite identification
    • Bateman, K.P. et al. MSE with mass defect fltering for in vitro and in vivo metabolite identification. Rapid Commun. Mass Spectrom. 21, 1485-1496(2007)
    • (2007) Rapid Commun. Mass Spectrom. , vol.21 , pp. 1485-1496
    • Bateman, K.P.1
  • 22
    • 46849091191 scopus 로고    scopus 로고
    • Mass defect profles of biological matrices and the general applicability of mass defect fltering for metabolite detection
    • Zhang, h., Zhu, M., Ray, K.L., Ma, L & Zhang, D. Mass defect profles of biological matrices and the general applicability of mass defect fltering for metabolite detection. Rapid Commun. Mass Spectrom. 22,2082-2088 (2008).
    • (2008) Rapid Commun. Mass Spectrom. , vol.22 , pp. 2082-2088
    • Zhang, H.1    Zhu, M.2    Ray, K.L.3    Ma, L.4    Zhang, D.5
  • 23
    • 62249093071 scopus 로고    scopus 로고
    • Assessment of three human in vitro systems in the generation of major human excretory and circulating metabolites
    • Dalvie, D. et al. assessment of three human in vitro systems in the generation of major human excretory and circulating metabolites. Chem. Res. Toxicol. 22,357-368 (2009).
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 357-368
    • Dalvie, D.1
  • 24
    • 62249183036 scopus 로고    scopus 로고
    • Predicting circulating human metabolites: How good are we?
    • Anderson, S., Lufer-atlas, D. & Knadler, M.P. Predicting circulating human metabolites: how good are we? Chem. Res. Toxicol. 22,243-256 (2009).
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 243-256
    • Anderson, S.1    Lufer-Atlas, D.2    Knadler, M.P.3
  • 25
    • 65249125136 scopus 로고    scopus 로고
    • Lc-MS/MS-based approach for obtaining exposure estimates of metabolites in early Clinical trials using radioactive metabolites as reference standards
    • Zhang, D. et al. Lc-MS/MS-based approach for obtaining exposure estimates of metabolites in early Clinical trials using radioactive metabolites as reference standards. Drug. Metab. Lett. 1, 293-298 (2007).
    • (2007) Drug. Metab. Lett. , vol.1 , pp. 293-298
    • Zhang, D.1
  • 26
    • 62249117708 scopus 로고    scopus 로고
    • Obtaining exposures of metabolites in preClinical species through plasma pooling and quantitative NMR: Addressing metabolites in safety testing (MIST) guidance without using radiolabeled compounds and chemically synthesized metabolite standards
    • Vishwanathan, K. et al. Obtaining exposures of metabolites in preClinical species through plasma pooling and quantitative NMR: addressing metabolites in safety testing (MIST) guidance without using radiolabeled compounds and chemically synthesized metabolite standards. Chem. Res. Toxicol. 22,311-322 (2009).
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 311-322
    • Vishwanathan, K.1
  • 27
    • 70350243185 scopus 로고    scopus 로고
    • A holistic strategy for characterizing the safety of metabolites through drug discovery and development
    • Walker, D. et al. a holistic strategy for characterizing the safety of metabolites through drug discovery and development. Chem Res. Toxicol. 22,1653-1662 (2009).
    • (2009) Chem Res. Toxicol. , vol.22 , pp. 1653-1662
    • Walker, D.1
  • 28
    • 33847081694 scopus 로고    scopus 로고
    • What is the objective of the mass balance study? a retrospective analysis of data in animal and human excretion studies employing radiolabeled drugs
    • Rofey, S.J., Obach, R.S., Gedge, J.I. & Smith, DA. What is the objective of the mass balance study? a retrospective analysis of data in animal and human excretion studies employing radiolabeled drugs. Drug Metab. Rev. 39, 17-43(2007).
    • (2007) Drug Metab. Rev. , vol.39 , pp. 17-43
    • Rofey, S.J.1    Obach, R.S.2    Gedge, J.I.3    Smith, D.A.4
  • 29
    • 33845734598 scopus 로고    scopus 로고
    • A regulatory perspective on issues and approaches in characterizing human metabolites
    • Davis-Bruno, K.L. & Atrakchi, A. A regulatory perspective on issues and approaches in characterizing human metabolites. Chem. Res. Toxicol. 19, 1561-1563(2006).
    • (2006) Chem. Res. Toxicol. , vol.19 , pp. 1561-1563
    • Davis-Bruno, K.L.1    Atrakchi, A.2
  • 30
    • 62249100639 scopus 로고    scopus 로고
    • Safety assessment of drug metabolites: Implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450s
    • Powley, M.W, Frederick, C.B., Sistare, F.D. & DeGeorge, J.J. Safety assessment of drug metabolites: implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450s. Chem. Res. Toxicol. 22,257-262 (2009).
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 257-262
    • Powley, M.W.1    Frederick, C.B.2    Sistare, F.D.3    Degeorge, J.J.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.