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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY. Piccoli S, et al. Among authors: green c. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675 Free article.
Recommendations for the development and validation of flow cytometry-based receptor occupancy assays.
Green CL, Stewart JJ, Högerkorp CM, Lackey A, Jones N, Liang M, Xu Y, Ferbas J, Moulard M, Czechowska K, Mc Closkey TW, van der Strate BW, Wilkins DE, Lanham D, Wyant T, Litwin V. Green CL, et al. Cytometry B Clin Cytom. 2016 Mar;90(2):141-9. doi: 10.1002/cyto.b.21339. Epub 2016 Feb 22. Cytometry B Clin Cytom. 2016. PMID: 26566147 Free article. Review.
Role of receptor occupancy assays by flow cytometry in drug development.
Stewart JJ, Green CL, Jones N, Liang M, Xu Y, Wilkins DE, Moulard M, Czechowska K, Lanham D, McCloskey TW, Ferbas J, van der Strate BW, Högerkorp CM, Wyant T, Lackey A, Litwin V. Stewart JJ, et al. Among authors: green cl. Cytometry B Clin Cytom. 2016 Mar;90(2):110-6. doi: 10.1002/cyto.b.21355. Epub 2016 Feb 16. Cytometry B Clin Cytom. 2016. PMID: 26704557 Free article. Review.
Receptor occupancy by flow cytometry.
Litwin V, Green C, Stewart JJ. Litwin V, et al. Among authors: green c. Cytometry B Clin Cytom. 2016 Mar;90(2):108-9. doi: 10.1002/cyto.b.21364. Cytometry B Clin Cytom. 2016. PMID: 27021410 Free article. No abstract available.
Flow Cytometry Method Validation Protocols.
Selliah N, Eck S, Green C, Oldaker T, Stewart J, Vitaliti A, Litwin V. Selliah N, et al. Among authors: green c. Curr Protoc Cytom. 2019 Jan;87(1):e53. doi: 10.1002/cpcy.53. Epub 2018 Nov 12. Curr Protoc Cytom. 2019. PMID: 30418706
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R. Stevenson L, et al. Among authors: green c. Bioanalysis. 2018 Dec;10(24):1973-2001. doi: 10.4155/bio-2018-0287. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488726 Free article. Review.
Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2018 Conference Workshops.
Czechowska K, Lannigan J, Wang L, Arcidiacono J, Ashhurst TM, Barnard RM, Bauer S, Bispo C, Bonilla DL, Brinkman RR, Cabanski M, Chang HD, Chakrabarti L, Chojnowski G, Cotleur B, Degheidy H, Dela Cruz GV, Eck S, Elliott J, Errington R, Filby A, Gagnon D, Gardner R, Green C, Gregory M, Groves CJ, Hall C, Hammes F, Hedrick M, Hoffman R, Icha J, Ivaska J, Jenner DC, Jones D, Kerckhof FM, Kukat C, Lanham D, Leavesley S, Lee M, Lin-Gibson S, Litwin V, Liu Y, Molloy J, Moore JS, Müller S, Nedbal J, Niesner R, Nitta N, Ohlsson-Wilhelm B, Paul NE, Perfetto S, Portat Z, Props R, Radtke S, Rayanki R, Rieger A, Rogers S, Rubbens P, Salomon R, Schiemann M, Sharpe J, Sonder SU, Stewart JJ, Sun Y, Ulrich H, Van Isterdael G, Vitaliti A, van Vreden C, Weber M, Zimmermann J, Vacca G, Wallace P, Tárnok A. Czechowska K, et al. Among authors: green c. Cytometry A. 2019 Jun;95(6):598-644. doi: 10.1002/cyto.a.23777. Cytometry A. 2019. PMID: 31207046 Free article. No abstract available.
A Cytometrist's Guide to Coordinating and Performing Effective COVID-19 Research.
Chattopadhyay PK, Filby A, Jellison ER, Ferrari G, Green C, Cherian S, Irish J, Litwin V; other members of the ISAC COVID-19 Work Group. Chattopadhyay PK, et al. Among authors: green c. Cytometry A. 2021 Jan;99(1):11-18. doi: 10.1002/cyto.a.24210. Epub 2020 Sep 8. Cytometry A. 2021. PMID: 32881296 Free PMC article. Review.
4,083 results