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Subset analysis of patients experiencing clinical events of a potentially immunogenic nature in the pivotal clinical trials of tocilizumab for rheumatoid arthritis: Evaluation of an antidrug antibody ELISA using clinical adverse event-driven immunogenicity testing.
Stubenrauch K, Wessels U, Birnboeck H, Ramirez F, Jahreis A, Schleypen J. Stubenrauch K, et al. Among authors: birnboeck h. Clin Ther. 2010 Aug;32(9):1597-609. doi: 10.1016/j.clinthera.2010.07.021. Clin Ther. 2010. PMID: 20974317
Low immunogenicity of tocilizumab in patients with rheumatoid arthritis.
Burmester GR, Choy E, Kivitz A, Ogata A, Bao M, Nomura A, Lacey S, Pei J, Reiss W, Pethoe-Schramm A, Mallalieu NL, Wallace T, Michalska M, Birnboeck H, Stubenrauch K, Genovese MC. Burmester GR, et al. Among authors: birnboeck h. Ann Rheum Dis. 2017 Jun;76(6):1078-1085. doi: 10.1136/annrheumdis-2016-210297. Epub 2016 Dec 22. Ann Rheum Dis. 2017. PMID: 28007755 Free article.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R. Richards S, et al. Among authors: birnboeck h. Bioanalysis. 2016 Dec;8(23):2475-2496. doi: 10.4155/bio-2016-4989. Bioanalysis. 2016. PMID: 27855512 Free article.
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