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Page 1
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: luna m. Bioanalysis. 2022 Feb;14(4):187-193. doi: 10.4155/bio-2022-0010. Bioanalysis. 2022. PMID: 35135309
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: luna m. Bioanalysis. 2019 Sep;11(18s):1-228. doi: 10.4155/bio-2019-0207. Epub 2019 Sep 30. Bioanalysis. 2019. PMID: 31565956
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: luna m. Bioanalysis. 2021 Apr;13(8):609-619. doi: 10.4155/bio-2021-0046. Epub 2021 Apr 13. Bioanalysis. 2021. PMID: 33847160
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: luna m. Bioanalysis. 2022 Jun;14(12):853-863. doi: 10.4155/bio-2022-0109. Epub 2022 Jun 15. Bioanalysis. 2022. PMID: 35703321
16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.
Zimmer J, Hays A, Lester T, Diaz M, Thomas E, O'Dell M, Hyer E, Tangri S, Dakappagari N, Yuan M, Lavelle A, Karnik S, Liu A, Xu B, Sales K, Gorityala S, Reynolds G, Sangster T, Franckaert D, Love I, Patel V, Roberge M, Lin J, Jerks E, Xu T, Garofolo W, Nadarajah S, Kernstock R, Dufield D, Ambrose D, Warrino D, Luna M, Marco CD, Tudoroniu A, Iordachescu A, Sanghvi M, Barton H, Brown M, Hoffpauir B, Rocha A, Dong K, Yamashita J. Zimmer J, et al. Among authors: luna m. Bioanalysis. 2024 Jun 2;16(11):505-517. doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12. Bioanalysis. 2024. PMID: 38864397
Sex Differences in Long COVID.
Shah DP, Thaweethai T, Karlson EW, Bonilla H, Horne BD, Mullington JM, Wisnivesky JP, Hornig M, Shinnick DJ, Klein JD, Erdmann NB, Brosnahan SB, Lee-Iannotti JK, Metz TD, Maughan C, Ofotokun I, Reeder HT, Stiles LE, Shaukat A, Hess R, Ashktorab H, Bartram L, Bassett IV, Becker JH, Brim H, Charney AW, Chopra T, Clifton RG, Deeks SG, Erlandson KM, Fierer DS, Flaherman VJ, Fonseca V, Gander JC, Hodder SL, Jacoby VL, Kotini-Shah P, Krishnan JA, Kumar A, Levy BD, Lieberman D, Lin JJ, Martin JN, McComsey GA, Moukabary T, Okumura MJ, Peluso MJ, Rosen CJ, Saade G, Shah PK, Sherif ZA, Taylor BS, Tuttle KR, Urdaneta AE, Wallick JA, Wiley Z, Zhang D, Horwitz LI, Foulkes AS, Singer NG; RECOVER Consortium. Shah DP, et al. JAMA Netw Open. 2025 Jan 2;8(1):e2455430. doi: 10.1001/jamanetworkopen.2024.55430. JAMA Netw Open. 2025. PMID: 39841477 Free PMC article.
Liquid Crystalline Networks Hamper the Malignancy of Cancer Cells.
Martella D, Tusa I, Tubita A, Negri A, Turriani M, Rojas-Rodríguez M, de Luna MS, Menconi A, Parmeggiani C, Rovida E. Martella D, et al. Among authors: de luna ms. Adv Healthc Mater. 2025 Jan 19:e2403607. doi: 10.1002/adhm.202403607. Online ahead of print. Adv Healthc Mater. 2025. PMID: 39828609
989 results