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Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Islam R, Kar S, Ritzén H, Hays A, Tayyem R, Barry C, Keyhani A, Zimmer J, Cruz Caturla M, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Hughes N, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Cape S, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Garofolo W, Savoie N, Brown M, Rhyne P, Hristopoulos G, Xu A, Goodwin L, Spriggs F, Xu A, Awaiye K, Hayes R, St Charles J, Bouhajib M, DiMarco C, DiMarco L, Savu SR, Bennett P, Kakkanaiah V, Nehls C, Stouffer B, Tabler E, Briscoe C, Karnik S, DuBey I, Kulagina N, Lindsay J, Beaver C, Williard C, Wang H, Feng H, Malone M, Wells E, Fang X, Moussallie M. Islam R, et al. Among authors: hays a. Bioanalysis. 2019 Apr;11(7):645-653. doi: 10.4155/bio-2019-0072. Epub 2019 Apr 17. Bioanalysis. 2019. PMID: 30993999
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Briscoe C, Hughes N, Hayes R, Islam R, Bennett P, Stouffer B, Cape S, Rhyne P, Beaver C, Charles JS, Kakkanaiah V, Xu A, Caturla MC, Spriggs F, Tayyem R, Barry C, Keyhani A, Zimmer J, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Matassa L, Garofolo W, Savoie N, Hristopoulos G, Xu A, Goodwin L, Awaiye K, Ritzén H, Bouhajib M, Marco CD, Savu SR, Nehls C, Tabler E, Hays A, Karnik S, Brown M, Lowes S, DuBey I, Kulagina N, Lindsay J, Williard C, Wang H, Malone M, Wells E, Fang X, Moussallie M. Briscoe C, et al. Among authors: hays a. Bioanalysis. 2019 Jun;11(12):1129-1138. doi: 10.4155/bio-2019-0131. Epub 2019 Jul 19. Bioanalysis. 2019. PMID: 31319683
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Bower J, Zimmer J, McCown S, Tabler E, Karnik S, Kar S, Sales K, Vance J, Barry C, Keyhani A, Williams D, Lester T, Garofolo F, Satterwhite C, Groeber E, Renfrew H, Lin J, Cape S, O'Dell M, Fang X, Brant A, Garofolo W, Savoie N, Hayes R, Simchik S, Sun R, Bravo O, Dufield D, Luna M, Xu A, Kane C, Farley E, Sanghvi M, Hays A, Lowes S, Islam R, Hoffpauir B, Beaver C, Dong K, Desai-Krieger D. Bower J, et al. Among authors: hays a. Bioanalysis. 2021 Apr;13(8):609-619. doi: 10.4155/bio-2021-0046. Epub 2021 Apr 13. Bioanalysis. 2021. PMID: 33847160
Recommendations on ELISpot assay validation by the GCC.
Islam R, Vance J, Poirier M, Zimmer J, Khadang A, Williams D, Zemo J, Lester T, Fjording M, Hays A, Hughes N, Garofolo F, Sheldon C, Guilbaud R, Satterwhite C, Colletti K, Groeber E, Renfrew H, Yu M, Lin J, Fang X, Wissel M, Beadnell T, Lin J, Shah S, Garofolo W, Savoie N, Hayes R, Pirro J, Kane C, Luna M, Xu A, Cape S, O'Dell M, Wheller R, Ritzen H, Farley E, Kierstead L, Mylott W, Tabler E, Yuan M, Karnik S, Voelker T, DuBey I, Williard C, Dong K, Shi J, Yamashita J. Islam R, et al. Among authors: hays a. Bioanalysis. 2022 Feb;14(4):187-193. doi: 10.4155/bio-2022-0010. Bioanalysis. 2022. PMID: 35135309
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: hays a. Bioanalysis. 2022 Jun;14(12):853-863. doi: 10.4155/bio-2022-0109. Epub 2022 Jun 15. Bioanalysis. 2022. PMID: 35703321
Neutralizing Antibody Validation Testing and Reporting Harmonization.
Myler H, Pedras-Vasconcelos J, Lester T, Civoli F, Xu W, Wu B, Vainshtein I, Luo L, Hassanein M, Liu S, Ramaswamy SS, Mora J, Pennucci J, McCush F, Lavelle A, Jani D, Ambakhutwala A, Baltrukonis D, Barker B, Carmean R, Chung S, Dai S, DeWall S, Dholakiya SL, Dodge R, Finco D, Yan H, Hays A, Hu Z, Inzano C, Kamen L, Lai CH, Meyer E, Nelson R, Paudel A, Phillips K, Poupart ME, Qu Q, Abhari MR, Ryding J, Sheldon C, Spriggs F, Warrino D, Wu Y, Yang L, Pasas-Farmer S. Myler H, et al. Among authors: hays a. AAPS J. 2023 Jul 8;25(4):69. doi: 10.1208/s12248-023-00830-5. AAPS J. 2023. PMID: 37421491
475 results