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Antidrug Antibody Assays for the clinical interpretation of immunogenicity 5 лет назад


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Antidrug Antibody Assays for the clinical interpretation of immunogenicity

I created this talk to explain the key elements of anti-drug antibody tests to help with the CLINICAL INTERPRETATION of IMMUNOGENICITY. Other videos in my series that cover the CLINICAL INTERPRETATION of IMMUNOGENICITY are: GENERAL PRINCIPLES FOR THE CLINICAL INTERPRETATION OF IMMUNOGENICITY AND GUIDELINES FOR ASSESSMENT OF THE CLINICAL INTERPRETATION OF IMMUNOGENICITY References I recommend: Maria-Dolores Vazquez-Abad, Immunogenicity Playlist YouTube    • Immunogenicity   Thomas Kirchlechner, 2013 M. Boudreau, Carolyn & Alter, Galit. (2019). Frontiers in Immunology. 10. 10.3389/fimmu.2019.00440 European Respiratory Journal 2010 36: 1185 DOI: 10.1183/09031936.00028510; Abbas, Lichtman and Pillai. Basic Immunology, 5th and 6th editions, 2019 Abbas, Lichtman, and Pillai. Cellular and Molecular Immunology, 9th edition; 2017 Front Immunol. 2014; 5: 520. doi: 10.3389/fimmu.2014.00520 Immunology Unit 1 Review and Project J. Immunol. Methods 289, 1-16. (2004) J. Pharm. Biomed. Anal. 48 (5), 1267-1281. (2008) Clin Chem. 51, 1983-1985. (2005) ASSAY and Drug Development Technologies. 5(5): 655-662. (2007). Bioanalysis 2 (4), 721-731(2010) Boris Gorovits: Bioanalytical Assays for Biotherapeutics 2017 ADME workshop; Fisher , T.S. et al.Cancer Immunology and Immunotherapy (2012) 61:1721-33 FDA Immunogenicity Assessment for Therapeutic Protein Products http://www.fda.gov/Drugs/GuidanceComp... EMA: Guideline on Immunogenicity assessment of therapeutic proteins 18 May 2017 EMEA/CHMP/BMWP/14327/2006 Rev 1 Glodsy et al Immunology 5th edition, 2003 J Allergy Clin Immunol 2005;115:584-91

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