The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals

PURPOSE: To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals. METHODS: A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for centrally approved biopharmaceuticals in the European Union between 1 July 2008 a...

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Autors principals: Ebbers, Hans C., Mantel-Teeuwisse, Aukje K., Sayed-Tabatabaei, Fakhredin A., Moors, Ellen H. M., Schellekens, Huub, Leufkens, Hubert G. M.
Format: Artigo
Idioma:Inglês
Publicat: Springer-Verlag 2012
Matèries:
Pharmacoepidemiology and Prescription
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC3548093/
https://ncbi.nlm.nih.gov/pubmed/22706615
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s00228-012-1317-3
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