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Page 1
Recommendations on qPCR/ddPCR assay validation by GCC.
Wissel M, Poirier M, Satterwhite C, Lin J, Islam R, Zimmer J, Khadang A, Zemo J, Lester T, Fjording M, Hays A, Hughes N, Garofolo F, Guilbaud R, Groeber E, Renfrew H, Colletti K, Yu M, Lin J, Fang X, Shah S, Garofolo W, Kar S, Hayes R, Pirro J, Kane C, Luna M, Xu A, Cape S, O'Dell M, Wheller R, Ritzen H, Vance J, Farley E, Matys K, Tabler E, Mylott W, Yuan M, Karnik S, Voelker T, DuBey I, Williard C, Shi J, Yamashita J. Wissel M, et al. Among authors: garofolo w. Bioanalysis. 2022 Jun;14(12):853-863. doi: 10.4155/bio-2022-0109. Epub 2022 Jun 15. Bioanalysis. 2022. PMID: 35703321
Global outsourcing.
Garofolo W, Garofolo F. Garofolo W, et al. Among authors: garofolo f. Bioanalysis. 2010 Feb;2(2):149-52. doi: 10.4155/bio.09.183. Bioanalysis. 2010. PMID: 21083294 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: garofolo f, garofolo w. Bioanalysis. 2011 Dec;3(24):2721-7. doi: 10.4155/bio.11.242. Bioanalysis. 2011. PMID: 22185271
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: garofolo f, garofolo w. 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: garofolo f, garofolo w. Bioanalysis. 2012 Apr;4(7):763-8. doi: 10.4155/bio.12.48. Bioanalysis. 2012. PMID: 22512795
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: garofolo f, garofolo w. 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: garofolo f, garofolo w. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394
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: garofolo w. Bioanalysis. 2012 Oct;4(19):2335-42. doi: 10.4155/bio.12.213. Bioanalysis. 2012. PMID: 23088460 No abstract available.
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: garofolo f, garofolo w. Bioanalysis. 2012 Oct;4(20):2439-46. doi: 10.4155/bio.12.197. Bioanalysis. 2012. PMID: 23157353
24 results