Analysis of immunogenicity data in the product information of biological drugs: a need to report immunogenicity data systematically

<p><strong>Objective</strong> The aim of this analysis was to evaluate whether the current unsystematic assessment leads to sufficient reporting of immunogenicity-related information in the Summary of Product Characteristics (SmPCs) of biological products approved in the European m...

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Detalhes bibliográficos
Main Authors: Borrega, R, Cruz, J, Taylor, P, Goncalves, J
Formato: Journal article
Idioma:English
Publicado em: Springer 2019