Antidrug Antibody Assays for the clinical interpretation of immunogenicity

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  • čas přidán 20. 07. 2024
  • 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 CZcams • 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
    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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