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Volumn 12, Issue 6, 2011, Pages 578-586

Addressing MIST (metabolites in safety testing): Bioanalytical approaches to address metabolite exposures in humans and animals

Author keywords

Drug metabolite safety assessment; HPLC MS MS; Metabolite quantitation; MIST; Peak area ratio; Radiometric quantitation

Indexed keywords

DRUG METABOLITE;

EID: 79957961908     PISSN: 13892002     EISSN: 18755453     Source Type: Journal    
DOI: 10.2174/138920011795713661     Document Type: Article
Times cited : (39)

References (38)
  • 2
    • 33845734598 scopus 로고    scopus 로고
    • A regulatory perspective on issues and approaches in characterizing human metabolites
    • DOI 10.1021/tx060203m
    • Davis-Bruno, K.L.; Atrakchi, A. A Regulatory Perspective on Issues and Approaches in Characterizing Human Metabolites. Chem. Res. Toxicol., 2006, 19, 1561-1563. (Pubitemid 44975118)
    • (2006) Chemical Research in Toxicology , vol.19 , Issue.12 , pp. 1561-1563
    • Davis-Bruno, K.L.1    Atrakchi, A.2
  • 3
    • 77957116776 scopus 로고    scopus 로고
    • Metabolites in safety testing
    • Robison, T.W.; Jacobs, A. Metabolites in safety testing. Bioanalysis, 2009, 1, 1193-1200.
    • (2009) Bioanalysis , vol.1 , pp. 1193-1200
    • Robison, T.W.1    Jacobs, A.2
  • 5
    • 85038490643 scopus 로고    scopus 로고
    • Accessed March 4, 2011
    • International Conference on Harmonization http://www.ich.org/products/ guidelines/safety/article/safetyguidelines. html (Accessed March 4, 2011.)
    • International Conference on Harmonization
  • 6
    • 33751249069 scopus 로고    scopus 로고
    • Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites
    • DOI 10.1016/j.taap.2006.08.009, PII S0041008X06002997
    • Prueksaritanont, T.; Lin, J.H.; Baillie, T.A. Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites. Toxicol. Appl. Pharmacol., 2006, 217, 143-152. (Pubitemid 44780764)
    • (2006) Toxicology and Applied Pharmacology , vol.217 , Issue.2 , pp. 143-152
    • Prueksaritanont, T.1    Lin, J.H.2    Baillie, T.A.3
  • 7
    • 33845748169 scopus 로고    scopus 로고
    • Metabolites and safety: What are the concerns, and how should we address them?
    • DOI 10.1021/tx0602012
    • Smith, D.A.; Obach, R.S. Metabolites and safety: what are the concerns, and how should we address them? Chem. Res. Toxicol., 2006, 19, 1570-1579. (Pubitemid 44975120)
    • (2006) Chemical Research in Toxicology , vol.19 , Issue.12 , pp. 1570-1579
    • Smith, D.A.1    Obach, R.S.2
  • 8
    • 78649231563 scopus 로고    scopus 로고
    • Challenges and solutions to metabolites in safety testing: Impact of the international conference on harmonization m3 (r2) guidance
    • Yu, H.; Bischoff, D.; Tweedie, D. Challenges and solutions to metabolites in safety testing: impact of the International Conference on Harmonization M3 (R2) guidance. Expert Opin. Drug Metab. Toxicol., 2010, 6, 1539-1549.
    • (2010) Expert Opin. Drug Metab. Toxicol. , vol.6 , pp. 1539-1549
    • Yu, H.1    Bischoff, D.2    Tweedie, D.3
  • 11
    • 79951896481 scopus 로고    scopus 로고
    • Best practices in a tiered approach to metabolite quantification: Views and recommendations of the european bioanalytical forum
    • Timmerman, P.; Kall, M.A.; Gordon, B.; Laakso, S.; Freisleben, A.; Hucker, R. Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalytical Forum. Bioanalysis, 2010, 2, 1185-1194.
    • (2010) Bioanalysis , vol.2 , pp. 1185-1194
    • Timmerman, P.1    Kall, M.A.2    Gordon, B.3    Laakso, S.4    Freisleben, A.5    Hucker, R.6
  • 12
    • 34247843033 scopus 로고    scopus 로고
    • Key elements of bioanalytical method validation for small molecules
    • Bansal, S.; DeStefano, A. Key Elements of Bioanalytical Method Validation for Small Molecules. AAPS Journal., 2007, 9, E109- E114.
    • (2007) AAPS Journal. , vol.9
    • Bansal, S.1    Destefano, A.2
  • 13
    • 77149125562 scopus 로고    scopus 로고
    • Metabolites in safety testing: "mIST" for the clinical pharmacologist
    • Frederick, C.B.; Obach, R.S. Metabolites in safety testing: "MIST" for the clinical pharmacologist. Clin. Pharmacol. Ther., 2010, 87, 345-350.
    • (2010) Clin. Pharmacol. Ther. , vol.87 , pp. 345-350
    • Frederick, C.B.1    Obach, R.S.2
  • 14
    • 0031719374 scopus 로고    scopus 로고
    • Role of drug disposition in drug hypersensitivity: A chemical, molecular, and clinical perspective
    • DOI 10.1021/tx980058f
    • Park, B.K.; Pirmohamed, M.; Kitteringham, N.R. Role of drug disposition in drug hypersensitivity: a chemical, molecular, and clinical perspective. Chem. Res. Toxicol., 1998, 11, 969-988. (Pubitemid 28447286)
    • (1998) Chemical Research in Toxicology , vol.11 , Issue.9 , pp. 969-988
    • Park, B.K.1    Pirmohamed, M.2    Kitteringham, N.R.3
  • 15
    • 78651403237 scopus 로고    scopus 로고
    • Metabolites: Have we MIST out the importance of structure and physicochemistry?
    • Smith, D.A.; Obach, R.S. Metabolites: have we MIST out the importance of structure and physicochemistry? Bioanalysis, 2010, 2, 1223-1233.
    • (2010) Bioanalysis , vol.2 , pp. 1223-1233
    • Smith, D.A.1    Obach, R.S.2
  • 16
    • 79952495863 scopus 로고    scopus 로고
    • Addressing metabolite safety during firstin- man studies using 14C-labeled drug and accelerator mass spectrometry
    • Lappin, G.; Seymour, M. Addressing metabolite safety during firstin- man studies using 14C-labeled drug and accelerator mass spectrometry. Bioanalysis, 2010, 2, 1315-1324.
    • (2010) Bioanalysis , vol.2 , pp. 1315-1324
    • Lappin, G.1    Seymour, M.2
  • 17
    • 62249142787 scopus 로고    scopus 로고
    • Which human metabolites have we MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development
    • Leclercq, L.; Cuyckens, F.; Mannens. S.J.G.; De Vries, R.; Timmerman, P.; Evans, D.C. Which human metabolites have we MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development. Chem. Res. Toxicol., 2009, 22, 280-293
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 280-293
    • Leclercq, L.1    Cuyckens, F.2    Mannens, S.J.G.3    De Vries, R.4    Timmerman, P.5    Evans, D.C.6
  • 18
    • 62249183036 scopus 로고    scopus 로고
    • Predicting circulating human metabolites: How good are we?
    • Anderson, S.; Luffer-Atlas, D.; Knadler, M.P. Predicting circulating human metabolites: how good are we? Chem. Res. Toxicol., 2009, 22, 243-256.
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 243-256
    • Anderson, S.1    Luffer-Atlas, D.2    Knadler, M.P.3
  • 20
    • 78649533107 scopus 로고
    • Mean serum level determination by assay of a single pooled sample
    • Hamilton, R.A.; Garnett, W.R.; Kline, B.J. Mean serum level determination by assay of a single pooled sample. Clin. Pharmacol. Ther., 1981, 29, 409-413.
    • (1981) Clin. Pharmacol. Ther. , vol.29 , pp. 409-413
    • Hamilton, R.A.1    Garnett, W.R.2    Kline, B.J.3
  • 21
    • 0031873679 scopus 로고    scopus 로고
    • Plasma-pooling methods to increase throughput for in vivo pharmacokinetic screening
    • DOI 10.1021/js970486q
    • Hop, C.E.C.A.; Wang, Z.; Chen, Q.; Kwei, G. Plasma-pooling methods to increase throughput for in vivo pharmacokinetic screening. J. Pharm. Sci., 1998, 87, 901-903. (Pubitemid 28319423)
    • (1998) Journal of Pharmaceutical Sciences , vol.87 , Issue.7 , pp. 901-903
    • Hop, C.E.C.A.1    Wang, Z.2    Chen, Q.3    Kwei, G.4
  • 22
    • 78649628659 scopus 로고    scopus 로고
    • A simple LC/MS/MS method to determine relative plasma exposures of drug metabolites across species for metabolite safety assessments
    • Gao, H.Y.; Deng, S.B.; Obach, R.S. A simple LC/MS/MS method to determine relative plasma exposures of drug metabolites across species for metabolite safety assessments. Drug Metab. Dispos., 2010, 38, 2147-2156.
    • (2010) Drug Metab. Dispos. , vol.38 , pp. 2147-2156
    • Gao, H.Y.1    Deng, S.B.2    Obach, R.S.3
  • 23
    • 78650423579 scopus 로고    scopus 로고
    • Determination of exposure multiples of human metabolites for mist assessment in preclinical safety species without using reference standards or radiolabeled compounds
    • Ma, S., Li, Z.; Lee, K.J.; Chowdhury, S.K. Determination of Exposure Multiples of Human Metabolites for MIST Assessment in Preclinical Safety Species without Using Reference Standards or Radiolabeled Compounds. Chem. Res. Toxicol., 2010, 23, 1871-1873.
    • (2010) Chem. Res. Toxicol. , vol.23 , pp. 1871-1873
    • Ma, S.1    Li, Z.2    Lee, K.J.3    Chowdhury, S.K.4
  • 24
    • 0028146445 scopus 로고
    • Novel carbamate metabolites of Mofegiline, a primary amine monoamine oxidase B inhibitor, in dogs and humans
    • Dow, J.; Piriou, F.; Wolf, E.; Dulery, B.D., Haegele, K.D. Novel carbamate metabolites of mofegiline, a primary amine monoamine oxidase B inhibitor, in dogs and humans. Drug Metab. Dispos., 1994, 22, 738-749. (Pubitemid 24307489)
    • (1994) Drug Metabolism and Disposition , vol.22 , Issue.5 , pp. 738-749
    • Dow, J.1    Piriou, F.2    Wolf, E.3    Dulery, B.D.4    Haegele, K.D.5
  • 26
    • 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.; Raghavan, N,; Chando, T.; Gambardella, J.; Fu, Y.; Zhang, D.; Unger, S.E.; Humphreys, W.G. LC-MS/MS-based approach for obtaining exposure estimates of metabolites in early clinical trials using radioactive metabolites as reference standards. Drug Metab. Lett., 2007, 1, 293-298.
    • (2007) Drug Metab. Lett. , vol.1 , pp. 293-298
    • Zhang, D.1    Raghavan, N.2    Chando, T.3    Gambardella, J.4    Fu, Y.5    Zhang, D.6    Unger, S.E.7    Humphreys, W.G.8
  • 27
    • 79952471135 scopus 로고    scopus 로고
    • A radiocalibration method with pseudo internal standard to estimate circulating metabolite concentrations
    • Yi, P.; Luffer-Atlas, D. A radiocalibration method with pseudo internal standard to estimate circulating metabolite concentrations. Bioanalysis, 2010, 2, 1195-1210.
    • (2010) Bioanalysis , vol.2 , pp. 1195-1210
    • Yi, P.1    Luffer-Atlas, D.2
  • 28
    • 12944265405 scopus 로고    scopus 로고
    • 1H NMR: Development and potential of a method for natural products analysis
    • DOI 10.1021/np0497301
    • Pauli, G.F.; Jaki, B.U.; Lankin, D.C. Quantitative 1H NMR: development and potential of a method for natural products analysis. J. Nat. Prod., 2005, 68, 133-149. (Pubitemid 40175949)
    • (2005) Journal of Natural Products , vol.68 , Issue.1 , pp. 133-149
    • Pauli, G.F.1    Jaki, B.U.2    Lankin, D.C.3
  • 29
    • 56549113149 scopus 로고    scopus 로고
    • Evaluation of preparative high performance liquid chromatography and cryoprobe- nuclear magnetic resonance spectroscopy for the early quantitative estimation of drug metabolites in human plasma
    • Dear, G.J.; Roberts, A.D.; Beaumont, C.; North, S.E. Evaluation of preparative high performance liquid chromatography and cryoprobe- nuclear magnetic resonance spectroscopy for the early quantitative estimation of drug metabolites in human plasma. J. Chrom. B., 2008, 876, 182-190.
    • (2008) J. Chrom. B. , vol.876 , pp. 182-190
    • Dear, G.J.1    Roberts, A.D.2    Beaumont, C.3    North, S.E.4
  • 30
    • 62249210251 scopus 로고    scopus 로고
    • Nuclear magnetic resonance spectroscopy as a quantitative tool to determine the concentrations of biologically produced metabolites: Implications in metabolites in safety testing
    • Espina. R.; Yu, L.; Wang, J.; Tong, Z.; Vashishtha, S.; Talaat, R.; Scatina, J.; Mutlib, A. Nuclear magnetic resonance spectroscopy as a quantitative tool to determine the concentrations of biologically produced metabolites: implications in metabolites in safety testing. Chem. Res. Toxicol., 2009, 22, 299-310.
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 299-310
    • Espina, R.1    Yu, L.2    Wang, J.3    Tong, Z.4    Vashishtha, S.5    Talaat, R.6    Scatina, J.7    Mutlib, A.8
  • 31
    • 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.; Babalola, K.; Wang, J.; Espina, R.; Yu, L.; Adedoyin, A.; Talaat, R.; Mutlib, A.; Scatina, J. 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., 2009, 22, 311-322.
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 311-322
    • Vishwanathan, K.1    Babalola, K.2    Wang, J.3    Espina, R.4    Yu, L.5    Adedoyin, A.6    Talaat, R.7    Mutlib, A.8    Scatina, J.9
  • 32
    • 79951931440 scopus 로고    scopus 로고
    • Validation of isolated metabolites from drug metabolism studies as analytical standards by quantitative nmr
    • Walker, G.S.; Ryder, T.F.; Sharma, R.; Smith, E.B.; Freund, A. Validation of Isolated Metabolites from Drug Metabolism Studies as Analytical Standards by Quantitative NMR. Drug Metab. Dispos., 2011, 39, 433-440.
    • (2011) Drug Metab. Dispos. , vol.39 , pp. 433-440
    • Walker, G.S.1    Ryder, T.F.2    Sharma, R.3    Smith, E.B.4    Freund, A.5
  • 33
    • 0034332544 scopus 로고    scopus 로고
    • Fluorine nuclear magnetic resonance: A privileged tool for metabolic studies of fluoropyrimidine drugs
    • Martino, R.; Malet-Martino, M.; Gilard, V. Fluorine nuclear magnetic resonance: a privileged tool for metabolic studies of fluoropyrimidine drugs. Curr. Drug Metab., 2000, 1, 271-303.
    • (2000) Curr. Drug Metab. , vol.1 , pp. 271-303
    • Martino, R.1    Malet-Martino, M.2    Gilard, V.3
  • 34
    • 33644688432 scopus 로고    scopus 로고
    • Fluorine nuclear magnetic resonance spectroscopy of human biofluids in the field of metabolic studies of anticancer and antifungal fluoropyrimidine drugs
    • DOI 10.1016/j.cca.2005.10.013, PII S0009898105006327
    • Malet-Martino, M.; Gilard, V.; Desmoulin, F.; Martino, R. Fluorine nuclear magnetic resonance spectroscopy of human biofluids in the field of metabolic studies of anticancer and antifungal fluoropyrimidine drugs. Clin. Chem. Acta, 2006, 366, 61-73. (Pubitemid 43330967)
    • (2006) Clinica Chimica Acta , vol.366 , Issue.1-2 , pp. 61-73
    • Malet-Martino, M.1    Gilard, V.2    Desmoulin, F.3    Martino, R.4
  • 35
    • 0036533298 scopus 로고    scopus 로고
    • A comparison of quantitative NMR and radiolabelling studies of the metabolism and excretion of Statil™ (3-(4-bromo-2-fluorobenzyl)-4-oxo-3H- phthalazin-1-ylacetic acid) in the rat
    • DOI 10.1016/S0731-7085(01)00637-9, PII S0731708501006379
    • Lenz, E.M., Wilson, I.D.; Wright, B.; Partridge, E.A.; Rodgers, E.T.; Haycock, P.R.; Lindon, J.C.; Nicholson, J.K. A comparison of quantitative NMR and radiolabelling studies on the metabolism of StatilTM (3-(4-bromo-2- fluorobenzyl)-4-oxo-3H-phthalazin-1- ylacetic acid) in the rat. J. Pharm. Biomed. Anal., 2002, 28, 31-43. (Pubitemid 34171644)
    • (2002) Journal of Pharmaceutical and Biomedical Analysis , vol.28 , Issue.1 , pp. 31-43
    • Lenz, E.M.1    Wilson, I.D.2    Wright, B.3    Partridge, E.A.4    Rodgers, C.T.5    Haycock, P.R.6    Lindon, J.C.7    Nicholson, J.K.8
  • 36
    • 33847184252 scopus 로고    scopus 로고
    • Workshop/conference report - Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
    • DOI 10.1208/aapsj0901004, 4
    • Viswanathan, C.T.; Bansal, S.; Booth, B.; DeStefano, A.J., Rose, M.J.; Sailstad, J.; Shah, V.P.; Skelly, J.P.; Swann, P.G.; Weiner, R. Workshop/Conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays. AAPS J., 2007, 9, E30-E42. (Pubitemid 46296546)
    • (2007) AAPS Journal , vol.9 , Issue.1
    • Viswanathan, C.T.1    Bansal, S.2    Booth, B.3    DeStefano, A.J.4    Rose, M.J.5    Sailstad, J.6    Shah, V.P.7    Skelly, J.P.8    Swann, P.G.9    Weiner, R.10
  • 37
    • 85038510216 scopus 로고    scopus 로고
    • FDA Guidance for Industry Accessed March 7, 2011
    • FDA Guidance for Industry www.fda.gov/downloads/Drugs/ GuidanceCompliancRegulatoryInformation/ Guidances/UCM070107.pdf (Accessed March 7, 2011)
  • 38
    • 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., 2009, 22, 1217-1220.
    • (2009) Chem. Res. Toxicol. , vol.22 , pp. 1217-1220
    • Atrakchi, A.H.1


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