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83 results
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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. Bowsher RR, et al. J Pharm Biomed Anal. 2008 Dec 15;48(5):1282-9. doi: 10.1016/j.jpba.2008.09.026. Epub 2008 Sep 27. J Pharm Biomed Anal. 2008. PMID: 18977625 Review.
Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development.
Khan MU, Bowsher RR, Cameron M, Devanarayan V, Keller S, King L, Lee J, Morimoto A, Rhyne P, Stephen L, Wu Y, Wyant T, Lachno DR. Khan MU, et al. Among authors: bowsher rr. Bioanalysis. 2015;7(2):229-42. doi: 10.4155/bio.14.274. Bioanalysis. 2015. PMID: 25587839 Free article.
Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development.
Nowatzke W, Cole TG, Bowsher RR. Nowatzke W, et al. Among authors: bowsher rr. Bioanalysis. 2010 Feb;2(2):237-47. doi: 10.4155/bio.09.191. Bioanalysis. 2010. PMID: 21083307 Review.
Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
Smolec J, DeSilva B, Smith W, Weiner R, Kelly M, Lee B, Khan M, Tacey R, Hill H, Celniker A, Shah V, Bowsher R, Mire-Sluis A, Findlay JW, Saltarelli M, Quarmby V, Lansky D, Dillard R, Ullmann M, Keller S, Karnes HT. Smolec J, et al. Pharm Res. 2005 Sep;22(9):1425-31. doi: 10.1007/s11095-005-5917-9. Epub 2005 Aug 24. Pharm Res. 2005. PMID: 16132353 Review.
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.
Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E. Shankar G, et al. J Pharm Biomed Anal. 2008 Dec 15;48(5):1267-81. doi: 10.1016/j.jpba.2008.09.020. Epub 2008 Sep 19. J Pharm Biomed Anal. 2008. PMID: 18993008 Review.
Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serum.
Ray CA, Bowsher RR, Smith WC, Devanarayan V, Willey MB, Brandt JT, Dean RA. Ray CA, et al. Among authors: bowsher rr. J Pharm Biomed Anal. 2005 Jan 4;36(5):1037-44. doi: 10.1016/j.jpba.2004.05.024. J Pharm Biomed Anal. 2005. PMID: 15620530
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. Lee JW, et al. Among authors: bowsher rr. Pharm Res. 2005 Apr;22(4):499-511. doi: 10.1007/s11095-005-2495-9. Epub 2005 Apr 7. Pharm Res. 2005. PMID: 15846456
Development of a novel radioimmunoassay to detect autoantibodies to amyloid beta peptides in the presence of a cross-reactive therapeutic antibody.
Sloan JH, Ackermann BJ, O'Dell M, Bowsher RR, Dean RA, Konrad RJ. Sloan JH, et al. Among authors: bowsher rr. J Pharm Biomed Anal. 2011 Dec 15;56(5):1029-34. doi: 10.1016/j.jpba.2011.08.006. Epub 2011 Aug 10. J Pharm Biomed Anal. 2011. PMID: 21868184
Development and validation of a noncompetitive electrochemiluminescence-based immunoassay (ECLIA) for specific determination of insulin lispro (Humalog®) in human serum to support pharmacokinetic assessments.
Simmons E, Johnson D, Delhaye R, Colwell J, Clor E, Santa P, Bowsher RR. Simmons E, et al. Among authors: bowsher rr. J Immunoassay Immunochem. 2019;40(3):314-327. doi: 10.1080/15321819.2019.1596950. Epub 2019 Mar 29. J Immunoassay Immunochem. 2019. PMID: 30924380
Application of size-exclusion chromatography in the investigation of the in vitro stability of proinsulin and its cleaved metabolites in human serum and plasma.
Bowsher RR, Santa PF. Bowsher RR, et al. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Mar 15;877(8-9):689-96. doi: 10.1016/j.jchromb.2009.01.035. Epub 2009 Jan 31. J Chromatogr B Analyt Technol Biomed Life Sci. 2009. PMID: 19223249
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