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Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).
Boterman M, Doig M, Breda M, Lowes S, Jersey J, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Cruz Caturla M, Couerbe P, Guittard J, Maltas J, Lansing T, Bhatti M, Schiebl C, Struwe P, Sheldon C, Hayes R, Sangster T, Pattison C, Bouchard J, Goodwin L, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Zimmer D, Folguera L, Zimmermann T, Pawula M, Moussallie M, Teixeira Lde S, Rocha T, Tang D, Jardieu P, Truog J, Lin J, Lundberg R, Cox C, Breau A, Bigogno C, Schoutsen D, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Nicholson R, Jenkins R, Lin MH, Karnik S, De Boer T, Houghton R, Green R, DeMaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Malone M, Best S, Fang X. Boterman M, et al. Among authors: needham s. Bioanalysis. 2012 Mar;4(6):651-60. doi: 10.4155/bio.12.18. Bioanalysis. 2012. PMID: 22452256 No abstract available.
4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.
Lowes S, Jersey J, Shoup R, Garofolo F, Needham S, Couerbe P, Lansing T, Bhatti M, Sheldon C, Hayes R, Islam R, Lin Z, Garofolo W, Moussallie M, Teixeira Lde S, Rocha T, Jardieu P, Truog J, Lin J, Lundberg R, Breau A, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Jenkins R, Nicholson R, Lin MH, Karnik S, DeMaio W, Smith K, Cojocaru L, Allen M, Fatmi S, Sayyarpour F, Malone M, Fang X. Lowes S, et al. Among authors: needham s. Bioanalysis. 2012 Apr;4(7):763-8. doi: 10.4155/bio.12.48. Bioanalysis. 2012. PMID: 22512795
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: needham s. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
Lowes S, Jersey J, Shoup R, Garofolo F, Savoie N, Mortz E, Needham S, Caturla MC, Steffen R, Sheldon C, Hayes R, Samuels T, Di Donato L, Kamerud J, Michael S, Lin ZJ, Hillier J, Moussallie M, de Souza Teixeira L, Rocci M, Buonarati M, Truog J, Hussain S, Lundberg R, Breau A, Zhang T, Jonker J, Berger N, Gagnon-Carignan S, Nehls C, Nicholson R, Hilhorst M, Karnik S, de Boer T, Houghton R, Smith K, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Vija J, Malone M, Heller D. Lowes S, et al. Among authors: needham s. Bioanalysis. 2011 Jun;3(12):1323-32. doi: 10.4155/bio.11.135. Bioanalysis. 2011. PMID: 21679026
Micro-LC-MS/MS: the future of bioanalysis.
Arnold DW, Needham SR. Arnold DW, et al. Bioanalysis. 2013 Jun;5(11):1329-31. doi: 10.4155/bio.13.31. Bioanalysis. 2013. PMID: 23742300 No abstract available.
97 results