Výsledky vyhledávání - "Balázs Vezér"

Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents

Autor: Zsuzsanna Buzás, Balázs Vezér, Zsombor Zrubka, Miklós Sebeszta

Publikováno v: Current medical research and opinion. 32(5)

Background The quality of biologicals, including biosimilars, is subject to change as a result of manufacturing process modifications following initial authorization. It is important that such product changes have no adverse impact on product efficac

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::df75e7ce8a8d56a6ed50a425c9c9102d
https://pubmed.ncbi.nlm.nih.gov/26808864

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