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    Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

    Immunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. To date, the descriptions of product immunogenicity have varied not only due to different degrees of unders...

    G. Shankar, S. Arkin, L. Cocea, V. Devanarayan, S. Kirshner… in The AAPS Journal (2014)