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Volumn 22, Issue 2, 2009, Pages 311-322

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

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE;

EID: 62249117708     PISSN: 0893228X     EISSN: 15205010     Source Type: Journal    
DOI: 10.1021/tx8003328     Document Type: Article
Times cited : (81)

References (28)
  • 1
    • 53549097600 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (, U.S. Food and Drug Administration, Center for Drug Evaluation and Research CDER, Rockville, MD
    • U.S. Food and Drug Administration (2008) Guidance for Industry: Safety Testing of Drug Metabolites, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD.
    • (2008) Guidance for Industry: Safety Testing of Drug Metabolites
  • 2
    • 33847166320 scopus 로고    scopus 로고
    • A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiomatic detection
    • Yu, C., Chen, L. C., Gorycki, F. L., and Neiss, T. G. (2007) A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiomatic detection. Rapid Commun. Mass. Spectrom. 21 (4), 497-502.
    • (2007) Rapid Commun. Mass. Spectrom , vol.21 , Issue.4 , pp. 497-502
    • Yu, C.1    Chen, L.C.2    Gorycki, F.L.3    Neiss, T.G.4
  • 3
    • 62249210251 scopus 로고    scopus 로고
    • Nuclear magnetic resonance as a quantitative tool to determine the concentrations of biologically produced metabolites: Implications in metabolites in safety testing
    • Espina, J. R., Yu, L., Wang, J., Tong, Z., Vashishtha, S., Talaat, R., Scatina, J., and Mutlib, A. E. (2008) Nuclear magnetic resonance as a quantitative tool to determine the concentrations of biologically produced metabolites: Implications in metabolites in safety testing. Chem. Res. Toxicol. 22, 299-310.
    • (2008) Chem. Res. Toxicol , vol.22 , pp. 299-310
    • Espina, J.R.1    Yu, L.2    Wang, J.3    Tong, Z.4    Vashishtha, S.5    Talaat, R.6    Scatina, J.7    Mutlib, A.E.8
  • 4
    • 0019461659 scopus 로고
    • Determination of mean valproic acid serum level by assay of a single pooled sample
    • Hamilton, R. A., Garnett, W. R., and Kline, B. J. (1981) Determination of mean valproic acid serum level by assay of a single pooled sample. Clin. Pharmacol. Ther. 29, 408-413.
    • (1981) Clin. Pharmacol. Ther , vol.29 , pp. 408-413
    • Hamilton, R.A.1    Garnett, W.R.2    Kline, B.J.3
  • 5
    • 0027285152 scopus 로고
    • Pooling plasmas for a rapid answer in pharmacokinetic studies: Application to a bioequivalence study of hydrocortisone tablets
    • Bouvier d'Yvoire, M., Coquerel, A, Chretien, P., and Tremblay, D. (1993) Pooling plasmas for a rapid answer in pharmacokinetic studies: application to a bioequivalence study of hydrocortisone tablets. Fundam. Clin. Pharmacol. 7, 253-260.
    • (1993) Fundam. Clin. Pharmacol , vol.7 , pp. 253-260
    • Bouvier d'Yvoire, M.1    Coquerel, A.2    Chretien, P.3    Tremblay, D.4
  • 6
    • 0025890208 scopus 로고
    • Determination of the relative formation and elimination clearance of two major carbamezepine metabolites in humans: A comparison between traditional and pooled sample analysis
    • Riad, L. E., Chan, K. K., and Sawchuk, R. J. (1991) Determination of the relative formation and elimination clearance of two major carbamezepine metabolites in humans: A comparison between traditional and pooled sample analysis. Pharmacol. Res. 8, 541-543.
    • (1991) Pharmacol. Res , vol.8 , pp. 541-543
    • Riad, L.E.1    Chan, K.K.2    Sawchuk, R.J.3
  • 7
    • 0031906913 scopus 로고    scopus 로고
    • Sample pooling to expedite bioanalysis and pharmacokinetic research
    • Kuo, B. S., Noord, T. V., Feng, M. R., and Wright, D. S. (1998) Sample pooling to expedite bioanalysis and pharmacokinetic research. J. Pharm. Biomed. Anal. 16, 837-846.
    • (1998) J. Pharm. Biomed. Anal , vol.16 , pp. 837-846
    • Kuo, B.S.1    Noord, T.V.2    Feng, M.R.3    Wright, D.S.4
  • 8
    • 0031873679 scopus 로고    scopus 로고
    • Plasma pooling methods to increase throughput for in vivo pharmacokinetic screening
    • Hop, C. E. C. A., Wang, Z., Chen, Q., and Kwei, G. (1998) Plasma pooling methods to increase throughput for in vivo pharmacokinetic screening. J. Pharm. Sci. 87, 901-903.
    • (1998) J. Pharm. Sci , vol.87 , pp. 901-903
    • Hop, C.E.C.A.1    Wang, Z.2    Chen, Q.3    Kwei, G.4
  • 9
    • 0036164807 scopus 로고    scopus 로고
    • Direct cocktail analysis of drug discovery compounds in pooled plasma samples using liquid-chromatography tandem mass spectrometry
    • Hsieh, Y., Bryant, M. S., Brisson, J. M., Ng, K., and Korfmacher, W. A. (2002) Direct cocktail analysis of drug discovery compounds in pooled plasma samples using liquid-chromatography tandem mass spectrometry. J. Chromatogr. B 767, 353-362.
    • (2002) J. Chromatogr. B , vol.767 , pp. 353-362
    • Hsieh, Y.1    Bryant, M.S.2    Brisson, J.M.3    Ng, K.4    Korfmacher, W.A.5
  • 11
    • 20044386199 scopus 로고    scopus 로고
    • Using sample pooling methods in the determination of AUC and AUMC in pharmacokinetic studies
    • Cheung, B. W. Y., Cartier, L. L., Russlie, H. Q., and Sawchuk, R. J. (2005) Using sample pooling methods in the determination of AUC and AUMC in pharmacokinetic studies. Fundam. Clin. Pharmacol. 19, 347-354.
    • (2005) Fundam. Clin. Pharmacol , vol.19 , pp. 347-354
    • Cheung, B.W.Y.1    Cartier, L.L.2    Russlie, H.Q.3    Sawchuk, R.J.4
  • 13
    • 53549097600 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (, U.S. Food and Drug Administration, Center for Drug Evaluation and Research CDER, Rockville, MD
    • U.S. Food and Drug Administration (2005) Guidance for Industry: Safety Testing of Drug Metabolites. Draft Guidance, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD.
    • (2005) Guidance for Industry: Safety Testing of Drug Metabolites. Draft Guidance
  • 14
    • 24944563781 scopus 로고    scopus 로고
    • Seeing through the mist: Abundance versus percentage. Commentary on metabolites in safety assessment
    • Smith, D. A., and Obach, R. S. (2005) Seeing through the mist: Abundance versus percentage. Commentary on metabolites in safety assessment. Drug Metab. Dispos. 33, 1409-1417.
    • (2005) Drug Metab. Dispos , vol.33 , pp. 1409-1417
    • Smith, D.A.1    Obach, R.S.2
  • 15
    • 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
  • 16
    • 33751249069 scopus 로고    scopus 로고
    • Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites
    • Prueksaritanont, T., Lin, J. H., and Baillie, T. (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
    • Prueksaritanont, T.1    Lin, J.H.2    Baillie, T.3
  • 17
    • 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, 1561-1569.
    • (2006) Chem. Res. Toxicol , vol.19 , pp. 1561-1569
    • Davis-Bruno, K.L.1    Atrakchi, A.2
  • 18
    • 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
  • 19
    • 33845769325 scopus 로고    scopus 로고
    • Safety assessment of drug metabolites: Characterization of chemically stable metabolites
    • Humphreys, W. G., and Unger, 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    Unger, S.E.2
  • 20
    • 33845340506 scopus 로고    scopus 로고
    • Future of toxicology. Mechanisms of toxicity and drug safety: Where do we go from here?
    • Stevens, J. L. (2006) Future of toxicology. Mechanisms of toxicity and drug safety: Where do we go from here? Chem. Res. Toxicol. 19, 1393-1401.
    • (2006) Chem. Res. Toxicol , vol.19 , pp. 1393-1401
    • Stevens, J.L.1
  • 21
    • 0038748909 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologies Evaluation and Research CBER, Rockville, MD
    • U.S. Food and Drug Administration (2000) Guidance for Industry: Analytical Procedures and Methods Validation Chemistry, Manufacturing and Controls Documentation, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologies Evaluation and Research (CBER), Rockville, MD.
    • (2000) Guidance for Industry: Analytical Procedures and Methods Validation Chemistry, Manufacturing and Controls Documentation
  • 22
    • 0003484310 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (, U.S. Food and Drug Administration, Center for Drug Evaluation and Research CDER, Rockville, MD
    • U.S. Food and Drug Administration (2001) Guidance for Industry: Bioanalytical Method Validation, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD.
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 25
    • 23644459107 scopus 로고    scopus 로고
    • Quantitative NMR in synthetic and combinatorial chemistry
    • Rizzo, V., and Pinciroli, V. (2005) Quantitative NMR in synthetic and combinatorial chemistry. J. Pharm. Biomed. Anal. 38, 851-857.
    • (2005) J. Pharm. Biomed. Anal , vol.38 , pp. 851-857
    • Rizzo, V.1    Pinciroli, V.2
  • 26
    • 12944265405 scopus 로고    scopus 로고
    • Quantitative 1H-NMR: Development and potential of a method for natural products analysis
    • Pauli, G. F., Jaki, B. U., and Lankin, D. C. (2005) Quantitative 1H-NMR: Development and potential of a method for natural products analysis. J. Nat. Prod. 68, 133-149.
    • (2005) J. Nat. Prod , vol.68 , pp. 133-149
    • Pauli, G.F.1    Jaki, B.U.2    Lankin, D.C.3
  • 28
    • 33847184252 scopus 로고    scopus 로고
    • Vishwanathan, C. T., Bansal, S., Booth, B., DeStefano, J., Rose, M. J., Sailstad, J., Shah, V. P., Skelly, J. P., Swann, P. G., and Weiner, R. (2007) Workshop/conference report - Quantitative bioanalytical methods and implementation: Best practices for chromatographic and ligand binding assays. AAPS J. 9, E30-E42.
    • Vishwanathan, C. T., Bansal, S., Booth, B., DeStefano, J., Rose, M. J., Sailstad, J., Shah, V. P., Skelly, J. P., Swann, P. G., and Weiner, R. (2007) Workshop/conference report - Quantitative bioanalytical methods and implementation: Best practices for chromatographic and ligand binding assays. AAPS J. 9, E30-E42.


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