메뉴 건너뛰기




Volumn , Issue , 2013, Pages 353-368

LC-MS Bioanalysis of Endogenous Compounds as Biomarkers

Author keywords

Assay validation; Bioanalysis; Biomarkers; Endogenous compounds; Fit for purpose; Liquid chromatography tandem mass spectrometry (LC MS)

Indexed keywords

DRUG PRODUCTS; ENZYME ACTIVITY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY;

EID: 84937493423     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118671276.ch28     Document Type: Chapter
Times cited : (6)

References (47)
  • 1
    • 67650564834 scopus 로고    scopus 로고
    • Multi-site assessment of the precision and reproducibility of multiple reaction monitoring-based measurements of proteins in plasma
    • Addona TA, Abbatiello SE, Schilling B, et al. Multi-site assessment of the precision and reproducibility of multiple reaction monitoring-based measurements of proteins in plasma. Nat Biotechnol 2009;27:633-641.
    • (2009) Nat Biotechnol , vol.27 , pp. 633-641
    • Addona, T.A.1    Abbatiello, S.E.2    Schilling, B.3
  • 2
    • 0027765639 scopus 로고
    • Optimal collection and storage conditions for catecholamine measurements in human plasma and urine
    • Boomsma F, Alberts G, Van Eijk L, Man In't Veld Aj, Schalekamp Ma. Optimal collection and storage conditions for catecholamine measurements in human plasma and urine. Clin Chem 1993;39:2503-2508.
    • (1993) Clin Chem , vol.39 , pp. 2503-2508
    • Boomsma, F.1    Alberts, G.2    Van Eijk, L.3    Aj, M.I.V.4    Ma, S.5
  • 3
    • 85019888879 scopus 로고    scopus 로고
    • Biomarkers Where we are going with method validation
    • Sept 11-14, Boston, MA
    • Booth B. Biomarkers Where we are going with method validation. Applied Pharmaceutical Analysis Meeting, Sept 11-14, 2011a, Boston, MA.
    • (2011) Applied Pharmaceutical Analysis Meeting
    • Booth, B.1
  • 4
    • 84859631569 scopus 로고    scopus 로고
    • When do you need a validated assay?
    • Booth B. When do you need a validated assay? Bioanalysis 2011b;3:2729-2730.
    • (2011) Bioanalysis , vol.3 , pp. 2729-2730
    • Booth, B.1
  • 5
    • 0009582144 scopus 로고
    • Arachidonic acid metabolism in polymorphonuclear leukocytes: unstable intermediate in formation of dihydroxy acids
    • Borgeat P, Samuelsson B. Arachidonic acid metabolism in polymorphonuclear leukocytes: unstable intermediate in formation of dihydroxy acids. Proc Natl Acad Sci USA 1979a;76:3213-3217.
    • (1979) Proc Natl Acad Sci USA , vol.76 , pp. 3213-3217
    • Borgeat, P.1    Samuelsson, B.2
  • 6
    • 0018710244 scopus 로고
    • Metabolism of arachidonic acid in polymorphonuclear leukocytes: structural analysis of novel hydroxylated compounds
    • Borgeat P, Samuelsson B. Metabolism of arachidonic acid in polymorphonuclear leukocytes: structural analysis of novel hydroxylated compounds. J Biol Chem 1979b;254:7865-7869.
    • (1979) J Biol Chem , vol.254 , pp. 7865-7869
    • Borgeat, P.1    Samuelsson, B.2
  • 7
    • 55349095003 scopus 로고    scopus 로고
    • Protein quantitation through targeted mass spectrometry: the way out of biomarker purgatory?
    • Carr SA, Anderson L. Protein quantitation through targeted mass spectrometry: the way out of biomarker purgatory? Clin Chem 2005;54:1749-1752.
    • (2005) Clin Chem , vol.54 , pp. 1749-1752
    • Carr, S.A.1    Anderson, L.2
  • 8
    • 58149154725 scopus 로고    scopus 로고
    • Validation of analytical methods for biomarkers used in drug development
    • Chau CH, Rixe O, Mcleod H, Figg WD. Validation of analytical methods for biomarkers used in drug development. Clin Cancer Res 2008;14:5967-5976.
    • (2008) Clin Cancer Res , vol.14 , pp. 5967-5976
    • Chau, C.H.1    Rixe, O.2    Mcleod, H.3    Figg, W.D.4
  • 9
    • 78650151240 scopus 로고    scopus 로고
    • Stable-isotope dilution LC-MS for quantitative biomarker analysis
    • Ciccimaro E, Blair IA. Stable-isotope dilution LC-MS for quantitative biomarker analysis. Bioanalysis 2010;2:311-341.
    • (2010) Bioanalysis , vol.2 , pp. 311-341
    • Ciccimaro, E.1    Blair, I.A.2
  • 11
    • 78049260524 scopus 로고    scopus 로고
    • Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
    • Cummings J, Raynaud F, Jones L, Sugar R, Dive C. Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs. Br J Cancer 2010;103:1313-1317.
    • (2010) Br J Cancer , vol.103 , pp. 1313-1317
    • Cummings, J.1    Raynaud, F.2    Jones, L.3    Sugar, R.4    Dive, C.5
  • 13
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
    • Desilva B, Smith W, Weiner R, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res 2003;20:1885-1900.
    • (2003) Pharm Res , vol.20 , pp. 1885-1900
    • Desilva, B.1    Smith, W.2    Weiner, R.3
  • 14
    • 68249147642 scopus 로고    scopus 로고
    • Workshop report and follow-up-AAPSWorkshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples-implications of Crystal City recommendations
    • Fast DM, Kelley M, Viswanathan CT, et al. Workshop report and follow-up-AAPSWorkshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples-implications of Crystal City recommendations. AAPS J 2009;11:238-241.
    • (2009) AAPS J , vol.11 , pp. 238-241
    • Fast, D.M.1    Kelley, M.2    Viswanathan, C.T.3
  • 15
    • 0003177157 scopus 로고    scopus 로고
    • Directive 2001/20/EC of the European Parliament and of the Council: on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
    • Fontaine N, Rosengren B. Directive 2001/20/EC of the European Parliament and of the Council: on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Commun 2001;L121:34-44.
    • (2001) Off J Eur Commun , vol.L121 , pp. 34-44
    • Fontaine, N.1    Rosengren, B.2
  • 16
    • 0025859904 scopus 로고
    • 6-trans-Leukotriene B4 is a neutrophil chemotoxin in the guinea pig dermis
    • Fretland DJW, Widomski DL, Anglin CP. 6-trans-Leukotriene B4 is a neutrophil chemotoxin in the guinea pig dermis. J Leukoc Biol 1991;49:283-288.
    • (1991) J Leukoc Biol , vol.49 , pp. 283-288
    • Fretland, D.J.W.1    Widomski, D.L.2    Anglin, C.P.3
  • 17
    • 80053013798 scopus 로고    scopus 로고
    • Quantification of 4-beta-hydroxycholesterol in human plasma using automated sample preparation and LC-ESI-MS/MS analysis
    • Goodenough AK, Onorato JM, Ouyang Z, et al. Quantification of 4-beta-hydroxycholesterol in human plasma using automated sample preparation and LC-ESI-MS/MS analysis. Chem Res Toxicol 2011;24:1575-1585.
    • (2011) Chem Res Toxicol , vol.24 , pp. 1575-1585
    • Goodenough, A.K.1    Onorato, J.M.2    Ouyang, Z.3
  • 18
    • 34047177929 scopus 로고    scopus 로고
    • Biomarker qualification pilot process at the US food and drug administration
    • Goodsaid F, Frueh F. Biomarker qualification pilot process at the US food and drug administration. AAPS J 2007;9:E105-108.
    • (2007) AAPS J , vol.9 , pp. E105-E108
    • Goodsaid, F.1    Frueh, F.2
  • 19
    • 3042547941 scopus 로고    scopus 로고
    • Effects of pharmacological doses of vitamin D3 on mineral balance and profiles of plasma vitamin D3 metabolites in horses
    • Harmeyer J, Schlumbohm C. Effects of pharmacological doses of vitamin D3 on mineral balance and profiles of plasma vitamin D3 metabolites in horses. J Steroid Biochem Mol Biol 2004;89-90:595-600.
    • (2004) J Steroid Biochem Mol Biol , vol.89-90 , pp. 595-600
    • Harmeyer, J.1    Schlumbohm, C.2
  • 20
    • 0344441315 scopus 로고    scopus 로고
    • Cellular accumulation of anandamide: consensus and controversy
    • Hillard CJ, Jarrahian A. Cellular accumulation of anandamide: consensus and controversy. Br J Pharmacol 2003;140:802-808.
    • (2003) Br J Pharmacol , vol.140 , pp. 802-808
    • Hillard, C.J.1    Jarrahian, A.2
  • 21
    • 85019897751 scopus 로고    scopus 로고
    • US Statutory Instrument 2004 No. 1031. The Medicines for Human Use (Clinical Trials) Regulations
    • HMSO. US Statutory Instrument 2004 No. 1031. The Medicines for Human Use (Clinical Trials) Regulations. 2004.
    • (2004)
  • 22
    • 85019965584 scopus 로고    scopus 로고
    • US Statutory Instrument 2006 No. 1928. The Medicines for Human Use (Clinical Trials) Regulations
    • HMSO. US Statutory Instrument 2006 No. 1928. The Medicines for Human Use (Clinical Trials) Regulations. 2006.
    • (2006)
  • 23
    • 77953479450 scopus 로고    scopus 로고
    • Generic approach to validation of small-molecule LC-MS/MS biomarker assays
    • Houghton R, Horro Pita C,Ward I, Macarthur R. Generic approach to validation of small-molecule LC-MS/MS biomarker assays. Bioanalysis 2009;1:1365-1374.
    • (2009) Bioanalysis , vol.1 , pp. 1365-1374
    • Houghton, R.1    Horro Pita, C.2    Ward, I.3    Macarthur, R.4
  • 24
    • 0043270582 scopus 로고    scopus 로고
    • Liquid chromatography/tandem mass spectrometry methods for quantitation of mevalonic acid in human plasma and urine: method validation, demonstration of using a surrogate analyte, and demonstration of unacceptable matrix effect in spite of use of a stable isotope analog internal standard
    • Jemal M, Schuster A, Whigan DB. Liquid chromatography/tandem mass spectrometry methods for quantitation of mevalonic acid in human plasma and urine: method validation, demonstration of using a surrogate analyte, and demonstration of unacceptable matrix effect in spite of use of a stable isotope analog internal standard. Rapid Commun Mass Spectrom 2003;17:1723-1734.
    • (2003) Rapid Commun Mass Spectrom , vol.17 , pp. 1723-1734
    • Jemal, M.1    Schuster, A.2    Whigan, D.B.3
  • 25
    • 77952745420 scopus 로고    scopus 로고
    • Validation and application of an LC-MS/MS method for quantitation of three fatty acid ethanolamides as biomarkers for fatty acid hydrolase inhibition in human plasma
    • Jian W, Edom R, Weng N, Zannikos P, Zhang Z, Wang H. Validation and application of an LC-MS/MS method for quantitation of three fatty acid ethanolamides as biomarkers for fatty acid hydrolase inhibition in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2010;878:1687-1699.
    • (2010) J Chromatogr B Analyt Technol Biomed Life Sci , vol.878 , pp. 1687-1699
    • Jian, W.1    Edom, R.2    Weng, N.3    Zannikos, P.4    Zhang, Z.5    Wang, H.6
  • 26
    • 24044482924 scopus 로고    scopus 로고
    • High-throughput analysis of vitamin C in human plasma with the use of HPLC with monolithic column and UV-detection
    • Karlsen A, Blomhoff R, Gundersen TE. High-throughput analysis of vitamin C in human plasma with the use of HPLC with monolithic column and UV-detection. J Chromatogr B Analyt Technol Biomed Life Sci 2005;824:132-138.
    • (2005) J Chromatogr B Analyt Technol Biomed Life Sci , vol.824 , pp. 132-138
    • Karlsen, A.1    Blomhoff, R.2    Gundersen, T.E.3
  • 27
    • 23244451582 scopus 로고    scopus 로고
    • Biomarkers and surrogate markers: an FDA perspective
    • Katz R. Biomarkers and surrogate markers: an FDA perspective. NeuroRx 2004;1:189-195.
    • (2004) NeuroRx , vol.1 , pp. 189-195
    • Katz, R.1
  • 28
    • 79953008926 scopus 로고    scopus 로고
    • Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics
    • Lee JW. Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics. Bioanalysis 2009;1:1461-1474.
    • (2009) Bioanalysis , vol.1 , pp. 1461-1474
    • Lee, J.W.1
  • 29
    • 32544451155 scopus 로고    scopus 로고
    • Fit-for-purpose method development and validation for successful biomarker measurement
    • Lee JW, Devanarayan V, Barrett YC, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 2006;23:312-328.
    • (2006) Pharm Res , vol.23 , pp. 312-328
    • Lee, J.W.1    Devanarayan, V.2    Barrett, Y.C.3
  • 30
    • 64149124608 scopus 로고    scopus 로고
    • Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis
    • Lee JW, Hall M. Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis. J Chromatogr B Analyt Technol Biomed Life Sci 2009;877:1259-1271.
    • (2009) J Chromatogr B Analyt Technol Biomed Life Sci , vol.877 , pp. 1259-1271
    • Lee, J.W.1    Hall, M.2
  • 31
    • 20944433395 scopus 로고    scopus 로고
    • Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report
    • Lee JW, Weiner RS, Sailstad JM, et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm Res 2005;22:499-511.
    • (2005) Pharm Res , vol.22 , pp. 499-511
    • Lee, J.W.1    Weiner, R.S.2    Sailstad, J.M.3
  • 32
    • 0021358920 scopus 로고
    • Characterization and biologic properties of 5,12-dihydroxy derivatives of eicosapentaenoic acid, including leukotriene B5 and the double lipoxygenase product
    • Lee TH, Menica-Huerta JM, Shih C, Corey EJ, Lewis RA, Austen KF. Characterization and biologic properties of 5,12-dihydroxy derivatives of eicosapentaenoic acid, including leukotriene B5 and the double lipoxygenase product. J Biol Chem 1984;259:2383-2389.
    • (1984) J Biol Chem , vol.259 , pp. 2383-2389
    • Lee, T.H.1    Menica-Huerta, J.M.2    Shih, C.3    Corey, E.J.4    Lewis, R.A.5    Austen, K.F.6
  • 33
    • 27544478172 scopus 로고    scopus 로고
    • Butyrylcholinesterase, paraoxonase, and albumin esterase, but not carboxylesterase, are present in human plasma
    • Li B, Sedlacek M, Manoharan I, et al. Butyrylcholinesterase, paraoxonase, and albumin esterase, but not carboxylesterase, are present in human plasma. Biochem Pharmacol 2005;70:1673-1684.
    • (2005) Biochem Pharmacol , vol.70 , pp. 1673-1684
    • Li, B.1    Sedlacek, M.2    Manoharan, I.3
  • 34
    • 0242354101 scopus 로고    scopus 로고
    • Quantitation of endogenous analytes in biofluid without a true blank matrix
    • Li W, Cohen LH. Quantitation of endogenous analytes in biofluid without a true blank matrix. Anal Chem 2003;75: 5854-5859.
    • (2003) Anal Chem , vol.75 , pp. 5854-5859
    • Li, W.1    Cohen, L.H.2
  • 35
    • 33745918301 scopus 로고    scopus 로고
    • Determination of S-phenylmercapturic acid in human urine using an automated sample extraction and fast liquid chromatography-tandem mass spectrometric method
    • Li Y, Li Ac, Shi H, et al. Determination of S-phenylmercapturic acid in human urine using an automated sample extraction and fast liquid chromatography-tandem mass spectrometric method. Biomed Chromatogr 2006;20:597-604.
    • (2006) Biomed Chromatogr , vol.20 , pp. 597-604
    • Li, Y.1    Ac, L.2    Shi, H.3
  • 36
    • 30444448196 scopus 로고    scopus 로고
    • Standard line slopes as a measure of a relative matrix effect in quantitative HPLC-MS bioanalysis
    • Matuszewski BK. Standard line slopes as a measure of a relative matrix effect in quantitative HPLC-MS bioanalysis. J Chromatogr B Analyt Technol Biomed Life Sci 2006;830:293-300.
    • (2006) J Chromatogr B Analyt Technol Biomed Life Sci , vol.830 , pp. 293-300
    • Matuszewski, B.K.1
  • 37
    • 0021260349 scopus 로고
    • Catabolism of N-acylethanolamine phospholipids by dog brain preparations
    • Natarajan V, Schmid PC, Reddy PV, Schmid HH. Catabolism of N-acylethanolamine phospholipids by dog brain preparations. J Neurochem 1984;42:1613-1619.
    • (1984) J Neurochem , vol.42 , pp. 1613-1619
    • Natarajan, V.1    Schmid, P.C.2    Reddy, P.V.3    Schmid, H.H.4
  • 38
    • 0035100888 scopus 로고    scopus 로고
    • Biomarkers and surrogate endpoints: preferred definitions and conceptual framework
    • NIH. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001;69: 89-95.
    • (2001) Clin Pharmacol Ther , vol.69 , pp. 89-95
  • 39
    • 77249165481 scopus 로고    scopus 로고
    • An immunoaffinity liquid chromatographytandem mass spectrometry assay for the quantitation of matrix metalloproteinase 9 in mouse serum
    • Ocana MF, Neubert H. An immunoaffinity liquid chromatographytandem mass spectrometry assay for the quantitation of matrix metalloproteinase 9 in mouse serum. Anal Biochem 2010;399:202-210.
    • (2010) Anal Biochem , vol.399 , pp. 202-210
    • Ocana, M.F.1    Neubert, H.2
  • 40
    • 8344285741 scopus 로고    scopus 로고
    • Development, validation and transfer of a hydrophilic interaction liquid chromatography/tandem mass spectrometric method for the analysis of the tobacco-specific nitrosamine metaboliteNNAL in human plasma at lowpicogram per milliliter concentrations
    • Pan J, Song Q, Shi H, et al. Development, validation and transfer of a hydrophilic interaction liquid chromatography/tandem mass spectrometric method for the analysis of the tobacco-specific nitrosamine metaboliteNNAL in human plasma at lowpicogram per milliliter concentrations. Rapid Commun Mass Spectrom 2004;18:2549-2557.
    • (2004) Rapid Commun Mass Spectrom , vol.18 , pp. 2549-2557
    • Pan, J.1    Song, Q.2    Shi, H.3
  • 42
    • 0029666285 scopus 로고    scopus 로고
    • Release of leukotriene A4 versus leukotriene B4 from human polymorphonuclear leukocytes
    • Sala A, Bolla M, Zarini S, Muller-Peddinghaus R, Folco G. Release of leukotriene A4 versus leukotriene B4 from human polymorphonuclear leukocytes. J Biol Chem 1996;271:17944-17948.
    • (1996) J Biol Chem , vol.271 , pp. 17944-17948
    • Sala, A.1    Bolla, M.2    Zarini, S.3    Muller-Peddinghaus, R.4    Folco, G.5
  • 44
    • 55549143295 scopus 로고    scopus 로고
    • Quantitative determination of endogenous compounds in biological samples using chromatographic techniques
    • VanDe Merbel NC. Quantitative determination of endogenous compounds in biological samples using chromatographic techniques. Trends in Analytical Chemistry 2008;27:924-933.
    • (2008) Trends in Analytical Chemistry , vol.27 , pp. 924-933
    • VanDe Merbel, N.C.1
  • 45
    • 34548550429 scopus 로고    scopus 로고
    • Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
    • Viswanathan CT, Bansal S, Booth B, et al. Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. Pharm Res 2007;24:1962-1973.
    • (2007) Pharm Res , vol.24 , pp. 1962-1973
    • Viswanathan, C.T.1    Bansal, S.2    Booth, B.3
  • 46
    • 77955417271 scopus 로고    scopus 로고
    • Quantification of circulating 25-hydroxyvitamin D by liquid chromatography-tandem mass spectrometry
    • Vogeser M. Quantification of circulating 25-hydroxyvitamin D by liquid chromatography-tandem mass spectrometry. J Steroid Biochem Mol Biol 2010;121:565-573.
    • (2010) J Steroid Biochem Mol Biol , vol.121 , pp. 565-573
    • Vogeser, M.1
  • 47
    • 33845974419 scopus 로고    scopus 로고
    • Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs
    • Wagner JA, Williams SA, Webster CJ. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin Pharmacol Ther 2007;81:104-107.
    • (2007) Clin Pharmacol Ther , vol.81 , pp. 104-107
    • Wagner, J.A.1    Williams, S.A.2    Webster, C.J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.