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Early antibody responses associated with survival in COVID19 patients.
Zhou ZH, Dharmarajan S, Lehtimaki M, Kirshner SL, Kozlowski S. Zhou ZH, et al. Among authors: kirshner sl. PLoS Pathog. 2021 Jul 19;17(7):e1009766. doi: 10.1371/journal.ppat.1009766. eCollection 2021 Jul. PLoS Pathog. 2021. PMID: 34280244 Free PMC article.
Anti-PEG IgE in anaphylaxis associated with polyethylene glycol.
Zhou ZH, Stone CA Jr, Jakubovic B, Phillips EJ, Sussman G, Park J, Hoang U, Kirshner SL, Levin R, Kozlowski S. Zhou ZH, et al. Among authors: kirshner sl. J Allergy Clin Immunol Pract. 2021 Apr;9(4):1731-1733.e3. doi: 10.1016/j.jaip.2020.11.011. Epub 2020 Nov 17. J Allergy Clin Immunol Pract. 2021. PMID: 33217616 Free PMC article. No abstract available.
Anti-drug Antibody Sample Testing and Reporting Harmonization.
Jani D, Marsden R, Gunsior M, Hay LS, Ward B, Cowan KJ, Azadeh M, Barker B, Cao L, Closson KR, Coble K, Dholakiya SL, Dusseault J, Hays A, Herl C, Hodsdon ME, Irvin SC, Kirshner S, Kolaitis G, Kulagina N, Kumar S, Lai CH, Lipari F, Liu S, Merdek KD, Moldovan IR, Mozaffari R, Pan L, Place C, Snoeck V, Manning MS, Stocker D, Tary-Lehmann M, Turner A, Vainshtein I, Verthelyi D, Williams WT, Yan H, Yan W, Yang L, Yang L, Zemo J, Zhong ZD. Jani D, et al. Among authors: kirshner s. AAPS J. 2022 Oct 28;24(6):113. doi: 10.1208/s12248-022-00762-6. AAPS J. 2022. PMID: 36307592
Anti-drug Antibody Validation Testing and Reporting Harmonization.
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, Devanaryan V, Gleason C, Goodman J, Manning MS, Purushothama S, Richards S, Shen H, Zoghbi J, Amaravadi L, Barger T, Bowen S, Bowsher RR, Clements-Egan A, Geng D, Goletz TJ, Gunn GR, Hallett W, Hodsdon ME, Janelsins BM, Jawa V, Kamondi S, Kirshner S, Kramer D, Liang M, Lindley K, Liu S, Liu Z, McNally J, Mikulskis A, Nelson R, Ahbari MR, Qu Q, Ruppel J, Snoeck V, Song A, Yan H, Ware M. Myler H, et al. AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y. AAPS J. 2021. PMID: 34853961 Free PMC article.
New FDA draft guidance on immunogenicity.
Parenky A, Myler H, Amaravadi L, Bechtold-Peters K, Rosenberg A, Kirshner S, Quarmby V. Parenky A, et al. AAPS J. 2014 May;16(3):499-503. doi: 10.1208/s12248-014-9587-6. Epub 2014 Mar 29. AAPS J. 2014. PMID: 24682766 Free PMC article.
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. Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226. Epub 2015 Dec 4. Bioanalysis. 2015. PMID: 26635247
87 results