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Results: 1 to 20 of 294

1.

Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report.

Lee JW, Weiner RS, Sailstad JM, Bowsher RR, Knuth DW, O'Brien PJ, Fourcroy JL, Dixit R, Pandite L, Pietrusko RG, Soares HD, Quarmby V, Vesterqvist OL, Potter DM, Witliff JL, Fritche HA, O'Leary T, Perlee L, Kadam S, Wagner JA.

Pharm Res. 2005 Apr;22(4):499-511. Epub 2005 Apr 7.

PMID:
15846456
[PubMed - indexed for MEDLINE]
2.

Fit-for-purpose method development and validation for successful biomarker measurement.

Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O'Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA.

Pharm Res. 2006 Feb;23(2):312-28. Epub 2006 Jan 12.

PMID:
16397743
[PubMed - indexed for MEDLINE]
3.

Biomarker assay translation from discovery to clinical studies in cancer drug development: quantification of emerging protein biomarkers.

Lee JW, Figeys D, Vasilescu J.

Adv Cancer Res. 2007;96:269-98. Review.

PMID:
17161683
[PubMed - indexed for MEDLINE]
4.

The applications of biomarkers in early clinical drug development to improve decision-making processes.

Kuhlmann J.

Ernst Schering Res Found Workshop. 2007;(59):29-45. Review.

PMID:
17117713
[PubMed - indexed for MEDLINE]
5.

Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies.

Valentin MA, Ma S, Zhao A, Legay F, Avrameas A.

J Pharm Biomed Anal. 2011 Jul 15;55(5):869-77. doi: 10.1016/j.jpba.2011.03.033. Epub 2011 Mar 29.

PMID:
21530130
[PubMed - indexed for MEDLINE]
6.

Biomarkers in drug discovery and development: from target identification through drug marketing.

Colburn WA.

J Clin Pharmacol. 2003 Apr;43(4):329-41. Review.

PMID:
12723454
[PubMed - indexed for MEDLINE]
7.

Conference Report: Analytical challenges in the qualification and validation of pharmacodynamic biomarkers.

Houghton R, Chamberlain J.

Bioanalysis. 2011 May;3(9):945-8. doi: 10.4155/bio.11.90.

PMID:
21545341
[PubMed - indexed for MEDLINE]
Free Article
8.

Translational medicine--a paradigm shift in modern drug discovery and development: the role of biomarkers.

Day M, Rutkowski JL, Feuerstein GZ.

Adv Exp Med Biol. 2009;655:1-12. doi: 10.1007/978-1-4419-1132-2_1. Review.

PMID:
20047030
[PubMed - indexed for MEDLINE]
9.

Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis.

Lee JW, Hall M.

J Chromatogr B Analyt Technol Biomed Life Sci. 2009 May 1;877(13):1259-71. doi: 10.1016/j.jchromb.2008.11.022. Epub 2008 Nov 18. Review.

PMID:
19038585
[PubMed - indexed for MEDLINE]
10.

Promises of biomarkers in drug development--a reality check.

Marrer E, Dieterle F.

Chem Biol Drug Des. 2007 Jun;69(6):381-94. Review.

PMID:
17581232
[PubMed - indexed for MEDLINE]
11.

Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents.

Dancey JE, Dobbin KK, Groshen S, Jessup JM, Hruszkewycz AH, Koehler M, Parchment R, Ratain MJ, Shankar LK, Stadler WM, True LD, Gravell A, Grever MR; Biomarkers Task Force of the NCI Investigational Drug Steering Committee.

Clin Cancer Res. 2010 Mar 15;16(6):1745-55. doi: 10.1158/1078-0432.CCR-09-2167. Epub 2010 Mar 9.

PMID:
20215558
[PubMed - indexed for MEDLINE]
Free Article
12.

Imaging as a Biomarker: Standards for Change Measurements in Therapy workshop summary.

Clarke LP, Sriram RD, Schilling LB.

Acad Radiol. 2008 Apr;15(4):501-30.

PMID:
18389935
[PubMed - indexed for MEDLINE]
13.

Translation of neurological biomarkers to clinically relevant platforms.

Hayes RL, Robinson G, Muller U, Wang KK.

Methods Mol Biol. 2009;566:303-13. doi: 10.1007/978-1-59745-562-6_20.

PMID:
20058180
[PubMed - indexed for MEDLINE]
14.

Biomarker discovery: validation and decision-making in product development.

Niedbala RS, Mauck C, Harrison P, Doncel GF.

Sex Transm Dis. 2009 Mar;36(3 Suppl):S76-80. doi: 10.1097/OLQ.0b013e31819cd800. Review.

PMID:
19218888
[PubMed - indexed for MEDLINE]
15.

Pharmacodynamic biomarkers for molecular cancer therapeutics.

Sarker D, Workman P.

Adv Cancer Res. 2007;96:213-68. Review.

PMID:
17161682
[PubMed - indexed for MEDLINE]
16.

Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design.

Maksymowych WP, Fitzgerald O, Wells GA, Gladman DD, Landewé R, Ostergaard M, Taylor WJ, Christensen R, Tak PP, Boers M, Syversen SW, Bathon JM, Ritchlin CJ, Mease PJ, Bykerk VP, Garnero P, Geusens P, El-Gabalawy H, Aletaha D, Inman RD, Kraus VB, Kvien TK, van der Heijde D.

J Rheumatol. 2009 Aug;36(8):1792-9. doi: 10.3899/jrheum090347.

PMID:
19671814
[PubMed - indexed for MEDLINE]
17.

Biomarkers of sepsis.

Marshall JC, Reinhart K; International Sepsis Forum.

Crit Care Med. 2009 Jul;37(7):2290-8. doi: 10.1097/CCM.0b013e3181a02afc. Review.

PMID:
19487943
[PubMed - indexed for MEDLINE]
18.

Conference report and review: current status of biomarkers potentially associated with prostate cancer outcomes.

Flaig TW, Nordeen SK, Lucia MS, Harrison GS, Glodé LM.

J Urol. 2007 Apr;177(4):1229-37. Review.

PMID:
17382696
[PubMed - indexed for MEDLINE]
19.

Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor kappaB ligand.

Bowsher RR, Sailstad JM.

J Pharm Biomed Anal. 2008 Dec 15;48(5):1282-9. doi: 10.1016/j.jpba.2008.09.026. Epub 2008 Sep 27. Review.

PMID:
18977625
[PubMed - indexed for MEDLINE]
20.

Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays.

Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R.

Pharm Res. 2007 Oct;24(10):1962-73. Epub 2007 Apr 26.

PMID:
17458684
[PubMed - indexed for MEDLINE]

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