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16 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. Among authors: 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. J Pharm Biomed Anal. 2008. PMID: 18977625 Review.
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: sailstad jm. Pharm Res. 2005 Apr;22(4):499-511. doi: 10.1007/s11095-005-2495-9. Epub 2005 Apr 7. Pharm Res. 2005. PMID: 15846456
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. Lee JW, et al. Pharm Res. 2006 Feb;23(2):312-28. doi: 10.1007/s11095-005-9045-3. Epub 2006 Jan 12. Pharm Res. 2006. PMID: 16397743
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. Viswanathan CT, et al. Pharm Res. 2007 Oct;24(10):1962-73. doi: 10.1007/s11095-007-9291-7. Epub 2007 Apr 26. Pharm Res. 2007. PMID: 17458684
Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves.
Azadeh M, Gorovits B, Kamerud J, MacMannis S, Safavi A, Sailstad J, Sondag P. Azadeh M, et al. AAPS J. 2017 Dec 27;20(1):22. doi: 10.1208/s12248-017-0159-4. AAPS J. 2017. PMID: 29282611
Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift.
Azadeh M, Sondag P, Wang Y, Raines M, Sailstad J. Azadeh M, et al. AAPS J. 2019 Jul 11;21(5):89. doi: 10.1208/s12248-019-0354-6. AAPS J. 2019. PMID: 31297703 Free PMC article.
A white paper--consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements.
Sailstad JM, Amaravadi L, Clements-Egan A, Gorovits B, Myler HA, Pillutla RC, Pursuhothama S, Putman M, Rose MK, Sonehara K, Tang L, Wustner JT; Global Bioanalysis Consortium. Sailstad JM, et al. AAPS J. 2014 May;16(3):488-98. doi: 10.1208/s12248-014-9582-y. Epub 2014 Mar 29. AAPS J. 2014. PMID: 24682765 Free PMC article. Review.
2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.
DeSilva B, Garofolo F, Rocci M, Martinez S, Dumont I, Landry F, Dicaire C, Szekely-Klepser G, Weiner R, Arnold M, Bansal S, Bateman K, Bauer R, Booth B, Davis S, Dudal S, Gouty D, Grundy J, Haidar S, Hayes R, Jemal M, Kaur S, Kelley M, Knutsson M, Le Blaye O, Lee J, Lowes S, Ma M, Mitsuoka T, Neto JT, Nicholson R, Ormsby E, Sailstad J, Stevenson L, Tang D, Welink J, Viswanathan CT, Wang L, Woolf E, Yang E. DeSilva B, et al. Bioanalysis. 2012 Sep;4(18):2213-26. doi: 10.4155/bio.12.205. Bioanalysis. 2012. PMID: 23046264
Technical aspects of inductively coupled plasma bioanalysis techniques.
Ammerman J, Huang C, Sailstad J, Wieling J, Whitmire ML, Wright D, de Lisio P, Keenan F, McCurdy E, Woods B, Wang P, Osredkar A, Ciaravino J. Ammerman J, et al. Bioanalysis. 2013 Aug;5(15):1831-41. doi: 10.4155/bio.13.146. Bioanalysis. 2013. PMID: 23905857
Application of commercial research-grade biomarker assays in drug development: is it time to create 'pharmaceutical-grade' kits?
Bowsher RR, Nowatzke W, Sailstad JM, Khan MU. Bowsher RR, et al. Among authors: sailstad jm. Bioanalysis. 2012 Oct;4(20):2427-30. doi: 10.4155/bio.12.238. Bioanalysis. 2012. PMID: 23157350 Free article. No abstract available.
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