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Page 1
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: struwe p. Bioanalysis. 2012 Mar;4(6):651-60. doi: 10.4155/bio.12.18. Bioanalysis. 2012. PMID: 22452256 No abstract available.
Conference report: the 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum.
Breda M, Garofolo F, Caturla MC, Couerbe P, Maltas J, White P, Struwe P, Sangster T, Riches S, Hillier J, Garofolo W, Zimmerman T, Pawula M, Collins E, Schoutsen D, Wieling J, Green R, Houghton R, Jeanbaptiste B, Claassen Q, Harter T, Seymour M. Breda M, et al. Among authors: struwe p. Bioanalysis. 2011 Dec;3(24):2721-7. doi: 10.4155/bio.11.242. Bioanalysis. 2011. PMID: 22185271
Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC).
Sangster T, Maltas J, Struwe P, Hillier J, Boterman M, Doig M, Breda M, Garofolo F, Caturla MC, Couerbe P, Schiebl C, Pattison C, Goodwin L, Segers R, Garofolo W, Folguera L, Zimmer D, Zimmerman T, Pawula M, Tang D, Cox C, Bigogno C, Schoutsen D, de Boer T, Green R, Houghton R, Sable R, Siethoff C, Harter T, Best S; Global CRO Council for Bioanalysis (GCC). Sangster T, et al. Among authors: struwe p. Bioanalysis. 2012 Jul;4(14):1723-30. doi: 10.4155/bio.12.172. Bioanalysis. 2012. PMID: 22877218 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: struwe p. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394
Recommendations on biomarker bioanalytical method validation by GCC.
Hougton R, Gouty D, Allinson J, Green R, Losauro M, Lowes S, LeLacheur R, Garofolo F, Couerbe P, Bronner S, Struwe P, Schiebl C, Sangster T, Pattison C, Islam R, Garofolo W, Pawula M, Buonarati M, Hayes R, Cameron M, Nicholson R, Harman J, Wieling J, De Boer T, Reuschel S, Cojocaru L, Harter T, Malone M, Nowatzke W. Hougton R, et al. Among authors: struwe p. Bioanalysis. 2012 Oct;4(20):2439-46. doi: 10.4155/bio.12.197. Bioanalysis. 2012. PMID: 23157353
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Bower J, Fast D, Garofolo F, Gouty D, Hayes R, Lowes S, Nicholson R, LeLacheur R, Bravo J, Shoup R, Dumont I, Carbone M, Zimmer J, Ortuno J, Caturla MC, Datin J, Lansing T, Fatmi S, Struwe P, Sheldon C, Islam R, Yu M, Hulse J, Kamerud J, Lin J, Doughty J, Kurylak K, Tang D, Buonarati M, Blanchette A, Levesque A, Gagnon-Carignan S, Lin J, Ray G, Liu Y, Khan M, Xu A, El-Sulayman G, DiMarco C, Bouhajib M, Tacey D, Jenkins R, der Strate Bv, Briscoe C, Karnik S, Rhyne P, Garofolo W, Schultz G, Roberts A, Redrup M, DuBey I, Conliffe P, Pekol T, Hantash J, Cojocaru L, Allen M, Reuschel S, Watson A, Farrell C, Groeber E, Malone M, Nowatzke W, Fang X. Bower J, et al. Among authors: struwe p. Bioanalysis. 2014;6(22):2957-63. doi: 10.4155/bio.14.287. Bioanalysis. 2014. PMID: 25496252
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse.
Timmerman P, Barfield M, Portabella EB, Calogero S, Cowan K, Faber J, Ferrari L, Golob M, Goodman J, Goodwin L, Gnoth MJ, Hughes R, Ivanova T, Jordan G, Laurén A, Maux D, McDougall S, Milushewa P, Nelson R, Pynaert G, Sklodowski K, Sleigh R, Struwe P, Verhaeghe T, Wheller R, White S, Zeiser K. Timmerman P, et al. Among authors: struwe p. Bioanalysis. 2024 Mar;16(5):259-270. doi: 10.4155/bio-2024-0013. Epub 2024 Feb 5. Bioanalysis. 2024. PMID: 38315622