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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: lester t. Bioanalysis. 2022 Jun;14(12):853-863. doi: 10.4155/bio-2022-0109. Epub 2022 Jun 15. Bioanalysis. 2022. PMID: 35703321 Free article.
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: lester t. AAPS J. 2023 Jul 8;25(4):69. doi: 10.1208/s12248-023-00830-5. AAPS J. 2023. PMID: 37421491
Perianal condylomata lata mimicking carcinoma.
Aung PP, Wimmer DB, Lester TR, Tetzlaff MT, Prieto VG. Aung PP, et al. Among authors: lester tr. J Cutan Pathol. 2022 Mar;49(3):209-214. doi: 10.1111/cup.13865. Epub 2021 Jan 20. J Cutan Pathol. 2022. PMID: 33470447 No abstract available.
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: lester t. Bioanalysis. 2022 Feb;14(4):187-193. doi: 10.4155/bio-2022-0010. Bioanalysis. 2022. PMID: 35135309 Free article.
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: lester t. Bioanalysis. 2021 Apr;13(8):609-619. doi: 10.4155/bio-2021-0046. Epub 2021 Apr 13. Bioanalysis. 2021. PMID: 33847160 Free article.