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Page 1
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: cojocaru l. Bioanalysis. 2014;6(22):2957-63. doi: 10.4155/bio.14.287. Bioanalysis. 2014. PMID: 25496252
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: cojocaru l. 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: cojocaru l. 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: cojocaru l. Bioanalysis. 2012 Oct;4(20):2439-46. doi: 10.4155/bio.12.197. Bioanalysis. 2012. PMID: 23157353
Recommendations on incurred sample stability (ISS) by GCC.
Lowes S, LeLacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Zimmer J, Caturla MC, Couerbe P, Awaiye K, Fatmi S, Farmen R, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Zhang T, Pasas-Farmer S, Garofolo W, Moussallie M, Rocci M, Allinson J, Gouty D, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Hayes R, Bouhajib M, Stipancic M, Nicholson R, Nehls C, Warren M, Karnik S, Houghton R, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, Watson A. Lowes S, et al. Among authors: cojocaru l. Bioanalysis. 2014 Sep;6(18):2385-90. doi: 10.4155/bio.14.155. Bioanalysis. 2014. PMID: 25384591
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Rocci M, Lowes S, Shoup R, Garofolo F, Farmen R, Zhang T, Allinson J, Gouty D, Hayes R, Nicholson R, Houghton R, Dumont I, LeLacheur R, Zimmer J, Cruz Caturla M, Couerbe P, Awaiye K, Fatmi S, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Pasas-Farmer S, Garofolo W, Moussallie M, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Bouhajib M, Stipancic M, Nehls C, Warren M, Karnik S, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, Watson A. Rocci M, et al. Among authors: cojocaru l. Bioanalysis. 2014 Oct;6(20):2713-20. doi: 10.4155/bio.14.231. Bioanalysis. 2014. PMID: 25413703 No abstract available.
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
Hayes R, LeLacheur R, Dumont I, Couerbe P, Safavi A, Islam R, Pattison C, Cape S, Rocci M, Briscoe C, Cojocaru L, Groeber E, Silvestro L, Bravo J, Shoup R, Verville M, Zimmer J, Caturla MC, Khadang A, Bourdage J, Hughes N, Fatmi S, Di Donato L, Sheldon C, Keyhani A, Satterwhite C, Yu M, Fiscella M, Hulse J, Lin ZJ, Garofolo W, Savoie N, Xiao YQ, Kurylak K, Harris S, Saxena M, Buonarati M, Lévesque A, Boudreau N, Lin J, Khan MU, Ray G, Liu Y, Xu A, Soni G, Ward I, Kingsley C, Ritzén H, Tabler E, Nicholson B, Bennett P, van de Merbel N, Karnik S, Bouhajib M, Wieling J, Mulvana D, Ingelse B, Allen M, Malone M, Fang X. Hayes R, et al. Among authors: cojocaru l. Bioanalysis. 2016 Mar;8(6):487-95. doi: 10.4155/bio.16.16. Epub 2016 Feb 26. Bioanalysis. 2016. PMID: 26916197
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
Cape S, Islam R, Nehls C, Allinson J, Safavi A, Bennett P, Hulse J, Beaver C, Khan M, Karnik S, Caturla MC, Lowes S, Iordachescu A, Silvestro L, Tayyem R, Shoup R, Mowery S, Keyhani A, Wakefield A, Li Y, Zimmer J, Torres J, Couerbe P, Khadang A, Bourdage J, Hughes N, Awaiye K, Matthews B, Fatmi S, Johnson R, Satterwhite C, Yu M, Lin J, Cojocaru L, Fiscella M, Thomas E, Kurylak K, Kamerud J, Lin ZJ, Garofolo W, Savoie N, Buonarati M, Boudreau N, Williard C, Liu Y, Warrino D, Kale P, Adcock N, Shekar R, O'Connor E, Ritzen H, Sanchez C, Hayes R, Bouhajib M, Savu SR, Stouffer B, Tabler E, Tu J, Briscoe C, der Strate BV, Rhyne P, Conliffe P, DuBey I, Yamashita J, Tang D, Groeber E, Vija J, Malone M, Osman M. Cape S, et al. Among authors: cojocaru l. Bioanalysis. 2017 Apr;9(7):505-516. doi: 10.4155/bio-2017-5000. Epub 2017 Mar 24. Bioanalysis. 2017. PMID: 28339299
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: cojocaru l. Bioanalysis. 2011 Jun;3(12):1323-32. doi: 10.4155/bio.11.135. Bioanalysis. 2011. PMID: 21679026
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: cojocaru l. Bioanalysis. 2012 Mar;4(6):651-60. doi: 10.4155/bio.12.18. Bioanalysis. 2012. PMID: 22452256 No abstract available.
73 results