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Explanation of the Guidelines for drug development related to immunogenicity assessment by the Food and Drug Administration and the European Medicine Agency.
References:
1. Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection FDA Guidance for Industry 2019
2. Immunogenicity Assessment of Therapeutic Protein Products —FDA Guidance for Industry 2014
3. EMA 2012 Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use
4. EMA 2017 Guideline on immunogenicity assessment of therapeutic proteins
5. Maria-Dolores Vazquez-Abad YouTube: Primary and Secondary Humoral Response [ Ссылка ]
6. Maria-Dolores Vazquez-Abad YouTube Playlist: Immunogenicity [ Ссылка ]
7. Maria-Dolores Vazquez-Abad YouTube: Types of Hypersensitivity responses [ Ссылка ]
8, Grodsky et all. Immunology 5th edition
9. YouTube by PhysioPathoPharmaco
9.1. Type I Hypersensitivity - Mechanism (Described Concisely)
9.2 Type II Hypersensitivity - Mechanisms (Described Concisely)
9.3 Type III Hypersensitivity
9.4 Type IV Hypersensitivity (Described Concisely)

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