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Page 1
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: reuschel s. Bioanalysis. 2012 Oct;4(20):2439-46. doi: 10.4155/bio.12.197. Bioanalysis. 2012. PMID: 23157353
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: reuschel s. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394
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: reuschel s. Bioanalysis. 2014;6(22):2957-63. doi: 10.4155/bio.14.287. Bioanalysis. 2014. PMID: 25496252
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: reuschel s. Bioanalysis. 2012 Oct;4(19):2335-42. doi: 10.4155/bio.12.213. Bioanalysis. 2012. PMID: 23088460 No abstract available.
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: reuschel s. 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: reuschel s. Bioanalysis. 2014 Oct;6(20):2713-20. doi: 10.4155/bio.14.231. Bioanalysis. 2014. PMID: 25413703 No abstract available.
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Nehls C, Buonarati M, Cape S, Islam R, Satterwhite C, Briscoe C, Hayes R, Dinan A, Sales K, Anderson S, Vance J, Lindsay J, Zimmer J, Couerbe P, Khadang A, Maasjo S, Bravo O, Lindley K, Moran L, Sangster T, Vija J, Stamatopoulos J, Lin J, Reuschel S, Underberg A, MacNeill R, Matassa L, Spytko A, Garofolo W, Savoie N, Rhyne P, Ambrosius J, Barra V, Dufield D, Luna M, Spriggs F, Fedorov E, Ritzén H, Fatmi S, Kane C, Bouhajib M, DiMarco C, Iordachescu A, Tudoroniu A, Farley E, Stouffer B, Tabler E, McCown S, Bower J, Harrison T, Karnik S, Brown M, Joyce P, DuBey I, Hoffpauir B, Boudreau N, Bergeron J, Wang H, Feng H, Zhou S, Wells E, Pirro J, Fang X, Shi J, Yang C. Nehls C, et al. Among authors: reuschel s. Bioanalysis. 2019 Sep;11(18s):1-228. doi: 10.4155/bio-2019-0207. Epub 2019 Sep 30. Bioanalysis. 2019. PMID: 31565956
24 results