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