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Volumn 1, Issue 8, 2009, Pages 1365-1374

Generic approach to validation of small?molecule LC-MS/MS biomarker assays

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; ETIOCHOLANOLONE; HYDROCORTISONE;

EID: 77953479450     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/BIO.09.139     Document Type: Article
Times cited : (63)

References (9)
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    • Viswanathan CT, Bansal S, Booth B et al. Workshop/Conference Report - quantitative bioanalyitcal methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9(1), 4 (2007).
    • (2007) AAPS J. , vol.9 , Issue.1 , pp. 4
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    • US FDA. US Department of Health and Human Services, US FDA, Centre for Drug Evaluation and Research, Rockville, MD, USA
    • US FDA. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, US FDA, Centre for Drug Evaluation and Research, Rockville, MD, USA (2001).
    • (2001) Guidance for Industry: Bioanalytical Method Validation
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    • Fit-for-purpose method development and validation for successful biomarker measurment
    • Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurment. Pharm. Res. 23(2), 312-328 (2006).
    • (2006) Pharm. Res. , vol.23 , Issue.2 , pp. 312-328
    • Lee, J.W.1    Devanarayan, V.2    Barrett, Y.C.3
  • 5
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    • 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. 20, 1885-1900 (2003).
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    • Desilva, B.1    Smith, W.2    Weiner, R.3
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    • 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 D. 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. 17, 1723-1734 (2003).
    • (2003) Rapid Commun. Mass Spectrom. , vol.17 , pp. 1723-1734
    • Jemal, M.1    Schuster, A.2    Whigan, D.3
  • 7
    • 58949095596 scopus 로고    scopus 로고
    • Development and validation of an LC-MS/ MS method for quantification of cyclic guanosine 3′,5′-monophosphate (cGMP) in clinical application: A comparison with an EIA method
    • Zhang Y, Dufield D, Klover J et al. Development and validation of an LC-MS/ MS method for quantification of cyclic guanosine 3′,5′- monophosphate (cGMP) in clinical application: a comparison with an EIA method. J. Chrom. B 877, 513-520 (2009).
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    • Zhang, Y.1    Dufield, D.2    Klover, J.3
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    • Does a stable isotopically labeled internal standard always correct analyte response? A matrix effect study on LC/MS/MS method for the determination of carvediol enantiomers in human plasma
    • Wang S, Cyronak M, Yang E. Does a stable isotopically labeled internal standard always correct analyte response? A matrix effect study on LC/MS/MS method for the determination of carvediol enantiomers in human plasma. J. Pharm. Biomed. Anal. 43, 701-707 (2007).
    • (2007) J. Pharm. Biomed. Anal. , vol.43 , pp. 701-707
    • Wang, S.1    Cyronak, M.2    Yang, E.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.