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Volumn 2, Issue 2, 2010, Pages 237-247

Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

EID: 79952509066     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.09.191     Document Type: Review
Times cited : (25)

References (22)
  • 1
    • 3142594816 scopus 로고    scopus 로고
    • Validation of assays for the bioanalysis of novel biomarkers
    • Bloom JC and Dean RA (Eds). Marcel Dekker, NY, USA
    • Lee JW, Smith WC, Nordblom GD, Bowsher RR. Validation of assays for the bioanalysis of novel biomarkers. In: Biomarkers in Clinical Drug Development. Bloom JC and Dean RA (Eds). Marcel Dekker, NY, USA, 119-149 (2003).
    • (2003) Biomarkers in Clinical Drug Development , pp. 119-149
    • Lee, J.W.1    Smith, W.C.2    Nordblom, G.D.3    Bowsher, R.R.4
  • 2
    • 67650639088 scopus 로고    scopus 로고
    • Chutes and ladders on the critical path: Comparative effectiveness, product value, and the use of biomarkers in drug development
    • Woodcock J. Chutes and ladders on the critical path: comparative effectiveness, product value, and the use of biomarkers in drug development. Clin. Pharmacol. Ther. 86(1), 12-14 (2009).
    • (2009) Clin. Pharmacol. Ther. , vol.86 , Issue.1 , pp. 12-14
    • Woodcock, J.1
  • 3
    • 0037380673 scopus 로고    scopus 로고
    • Biomarkers in drug discovery and development: From target identification through drug marketing
    • DOI 10.1177/0091270003252480
    • Colburn WA. Biomarkers in drug discovery and development: from target identification through drug marketing. J. Clin. Pharmacol. 43(4), 329-341 (2003). (Pubitemid 36368776)
    • (2003) Journal of Clinical Pharmacology , vol.43 , Issue.4 , pp. 329-341
    • Colburn, W.A.1    Keefe, D.L.2
  • 4
    • 33750515034 scopus 로고    scopus 로고
    • A cost-effectiveness approach to the qualification and acceptance of biomarkers
    • DOI 10.1038/nrd2174, PII NRD2174
    • Williams SA, Slavin DE, Wagner JA, Webster CJ. A cost-effectiveness approach to the qualification and acceptance of biomarkers. Nat. Rev. Drug Discov. 5(11), 897-902 (2006). (Pubitemid 44660603)
    • (2006) Nature Reviews Drug Discovery , vol.5 , Issue.11 , pp. 897-902
    • Williams, S.A.1    Slavin, D.E.2    Wagner, J.A.3    Webster, C.J.4
  • 5
    • 33845974419 scopus 로고    scopus 로고
    • Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs
    • DOI 10.1038/sj.clpt.6100017, PII 6100017
    • 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. 81(1), 104-7 (2007). (Pubitemid 46050874)
    • (2007) Clinical Pharmacology and Therapeutics , vol.81 , Issue.1 , pp. 104-107
    • Wagner, J.A.1    Williams, S.A.2    Webster, C.J.3
  • 6
    • 33747030845 scopus 로고    scopus 로고
    • Protein biomarker discovery and validation: The long and uncertain path to clinical utility
    • DOI 10.1038/nbt1235, PII NBT1235
    • Rifai N, Gillette MA, Carr SA. Protein biomarker discovery and validation: the long and uncertain path to clinical utility. Nat. Biotechnol. 24(8), 971-83 (2006). (Pubitemid 44215392)
    • (2006) Nature Biotechnology , vol.24 , Issue.8 , pp. 971-983
    • Rifai, N.1    Gillette, M.A.2    Carr, S.A.3
  • 7
    • 0026606194 scopus 로고
    • Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies
    • Shah VP, Midha KK, Dighe S, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Pharm. Res. 9, 588-592 (1992).
    • (1992) Pharm. Res. , vol.9 , pp. 588-592
    • Shah, V.P.1    Midha, K.K.2    Dighe, S.3
  • 8
    • 18044384682 scopus 로고    scopus 로고
    • Guidance for Industry On Bioanalytical Method Validation
    • Guidance for Industry On Bioanalytical Method Validation. Federal Register 66, 28526-28527 (2001).
    • (2001) Federal Register , vol.66 , pp. 28526-28527
  • 11
    • 58249134378 scopus 로고    scopus 로고
    • Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug metabolism: Bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor kb ligand
    • Bowsher RR, Sailstad JM. Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug metabolism: bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor kb ligand. J. Pharm. Biomed. Anal. 48, 1282-1289 (2008).
    • (2008) J. Pharm. Biomed. Anal. , vol.48 , pp. 1282-1289
    • Bowsher, R.R.1    Sailstad, J.M.2
  • 12
    • 58149154725 scopus 로고    scopus 로고
    • Validation of analytical methods for biomarkers used in drug development
    • Chau CH, Rixie O, McLeod H, et al. Validation of analytical methods for biomarkers used in drug development. Clin. Cancer Res. 14(19), 5967-5976 (2008).
    • (2008) Clin. Cancer Res. , vol.14 , Issue.19 , pp. 5967-5976
    • Chau, C.H.1    Rixie, O.2    McLeod, H.3
  • 13
    • 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. Chromatrogr. B 877, 1259-1271 (2009).
    • (2009) J. Chromatrogr. B , vol.877 , pp. 1259-1271
    • Lee, J.W.1    Hall, M.2
  • 17
    • 0019796502 scopus 로고    scopus 로고
    • A multi-rule shewhart chart for quality control in clinical chemistry
    • Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule shewhart chart for quality control in clinical chemistry. Clin. Chem. 27, 493-501 (2001).
    • (2001) Clin. Chem. , vol.27 , pp. 493-501
    • Westgard, J.O.1    Barry, P.L.2    Hunt, M.R.3    Groth, T.4
  • 18
    • 68249144517 scopus 로고    scopus 로고
    • "Fit-for-purpose" method validation and application of a biomarker (c-terminal telopeptides of type 1 collagen) in denosumab clinical studies
    • Wang J, Lee J, Burns D, et al. "Fit-for-purpose" method validation and application of a biomarker (c-terminal telopeptides of type 1 collagen) in denosumab clinical studies. AAPS J. 11(2), 385-394 (2009).
    • (2009) AAPS J. , vol.11 , Issue.2 , pp. 385-394
    • Wang, J.1    Lee, J.2    Burns, D.3
  • 19
    • 56549117782 scopus 로고    scopus 로고
    • Reference materials and reference measurement procedures: An overview from a national metrology institute
    • Bunk DM. Reference materials and reference measurement procedures: an overview from a national metrology institute. Clin. Biochem. Rev. 28, 131-137 (2007).
    • (2007) Clin. Biochem. Rev. , vol.28 , pp. 131-137
    • Bunk, D.M.1
  • 20
    • 79953325059 scopus 로고    scopus 로고
    • Department of Health and Human Services, Food and Drug Administration Laboratory Requirements, Section 2 Definitions
    • Department of Health and Human Services, Food and Drug Administration. 42 CFR Part 493, Laboratory Requirements, Section 2 Definitions (2004).
    • (2004) 42 CFR Part 493


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