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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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| 主要な著者: | , , , , , |
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| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
Springer-Verlag
2012
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| 主題: | |
| オンライン･アクセス: | 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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