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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. Among authors: lanham d. 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: lanham d. 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.
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: lanham d. Cytometry A. 2019 Jun;95(6):598-644. doi: 10.1002/cyto.a.23777. Cytometry A. 2019. PMID: 31207046 Free article. No abstract available.
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: lanham d. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675 Free article.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Nuti S, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Exley A, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L. Spitz S, et al. Among authors: lanham d. Bioanalysis. 2021 Mar;13(5):295-361. doi: 10.4155/bio-2021-0005. Epub 2021 Jan 29. Bioanalysis. 2021. PMID: 33511867 Free article.
Target engagement and cellular fate of otelixizumab: a repeat dose escalation study of an anti-CD3ε mAb in new-onset type 1 diabetes mellitus patients.
Vlasakakis G, Napolitano A, Barnard R, Brown K, Bullman J, Inman D, Keymeulen B, Lanham D, Leirens Q, MacDonald A, Mezzalana E, Page K, Patel M, Savage CO, Zamuner S, van Maurik A. Vlasakakis G, et al. Among authors: lanham d. Br J Clin Pharmacol. 2019 Apr;85(4):704-714. doi: 10.1111/bcp.13842. Epub 2019 Feb 5. Br J Clin Pharmacol. 2019. PMID: 30566758 Free PMC article. Clinical Trial.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L, Fraser S, Gorovits B, Allinson J, Barger T, Chilewski S, Fjording MS, Haidar S, Islam R, Jaitner B, Kamerud J, Katori N, Krinos-Fiorotti C, Lanham D, Ma M, McNally J, Morimoto A, Mytych D, Nogueira da Costa A, Papadimitriou A, Pillutla R, Ray S, Safavi A, Savoie N, Schaefer M, Shih J, Smeraglia J, Skelly MF, Spond J, Staack RF, Stouffer B, Tampal N, Torri A, Welink J, Yang TY, Zoghbi J. Amaravadi L, et al. Among authors: lanham d. Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226. Epub 2015 Dec 4. Bioanalysis. 2015. PMID: 26635247 Free article.
Extremes of baseline cognitive function determine the severity of delirium: a population study.
Tsui A, Yeo N, Searle SD, Bowden H, Hoffmann K, Hornby J, Goslett A, Weston-Clarke M, Lanham D, Hogan P, Seeley A, Rawle M, Chaturvedi N, Sampson EL, Rockwood K, Cunningham C, Ely EW, Richardson SJ, Brayne C, Terrera GM, Tieges Z, MacLullich AMJ, Davis D. Tsui A, et al. Among authors: lanham d. Brain. 2023 May 2;146(5):2132-2141. doi: 10.1093/brain/awad062. Brain. 2023. PMID: 36856697 Free PMC article.
44 results