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Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.
Nicholson R, Lowes S, Caturla MC, Safavi A, Mamelak D, Islam R, Allinson J, Gouty D, Khan M, Lelacheur R, Shoup R, Martinez S, Dumont I, Zimmer J, Steffen R, Petrilla J, Awaiye K, Sheldon C, Turk D, Fast D, Kamerud J, Dinan A, Lin ZJ, Garofolo W, Tang D, Wright L, Lin J, Yamashita Y, Liu Y, Xu A, Hayes R, Bouhajib M, Levesque A, Gagnon-Carignan S, Harman J, Warren M, Karnik S, Cojocaru L, Reuschel S, Gonzalez P, Fatmi S, Vija J, Rock M, Malone M, Nowatzke W, Fang X. Nicholson R, et al. Among authors: rock m. Bioanalysis. 2012 Oct;4(19):2335-42. doi: 10.4155/bio.12.213. Bioanalysis. 2012. PMID: 23088460 No abstract available.
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Lowes S, Boterman M, Doig M, Breda M, Jersey J, Lelacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Zimmer J, Caturla MC, Couerbe P, Maltas J, Steffen R, Petrilla J, Safavi A, Awaiye K, Bhatti M, Sheldon C, Schiebl C, Struwe P, Turk D, Sangster T, Pattison C, Fast D, Goodwin L, Kamerud J, Dinan A, Mamelak D, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Folguera L, Zimmer D, Zimmermann T, Pawula M, Moussallie M, de Souza Teixeira L, Rocha T, Allinson J, Jardieu P, Tang D, Gouty D, Wright L, Truog J, Lin J, Yamashita Y, Khan M, Liu Y, Xu A, Lundberg R, Cox C, Breau A, Hayes R, Bigogno C, Schoutsen D, Dilger C, Jonker J, Bouhajib M, Levesque A, Gagnon-Carignan S, Harman J, Nicholson R, Jenkins R, Warren M, Lin MH, Karnik S, De Boer T, Houghton R, Green R, Demaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Reuschel S, Gonzalez P, Harter T, Fatmi S, Rock M, Vija J, Sayyarpour F, Malone M, Nowatzke W, Best S, Fang X. Lowes S, et al. Among authors: rock m. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394
Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.
Booth B, Arnold ME, DeSilva B, Amaravadi L, Dudal S, Fluhler E, Gorovits B, Haidar SH, Kadavil J, Lowes S, Nicholson R, Rock M, Skelly M, Stevenson L, Subramaniam S, Weiner R, Woolf E. Booth B, et al. Among authors: rock m. AAPS J. 2015 Mar;17(2):277-88. doi: 10.1208/s12248-014-9696-2. Epub 2014 Dec 31. AAPS J. 2015. PMID: 25549614 Free PMC article.
Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment.
Kelley M, Stevenson L, Golob M, Devanarayan V, Pedras-Vasconcelos J, Staack RF, Jenkins R, Booth B, Wakshull E, Bowsher R, Rock M, Dudal S, DeSilva B. Kelley M, et al. Among authors: rock m. AAPS J. 2015 Jul;17(4):1019-24. doi: 10.1208/s12248-015-9767-z. Epub 2015 Apr 30. AAPS J. 2015. PMID: 25921938 Free PMC article.
489 results