טוען...
Expanded Access as a source of real‐world data: An overview of FDA and EMA approvals
AIMS: To identify, characterize and compare all Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals that included real‐world data on efficacy from expanded access (EA) programmes. METHODS: Cross‐sectional study of FDA (1955–2018) and EMA (1995–2018) regulatory approval d...
שמור ב:
| הוצא לאור ב: | Br J Clin Pharmacol |
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| Main Authors: | , , |
| פורמט: | Artigo |
| שפה: | Inglês |
| יצא לאור: |
John Wiley and Sons Inc.
2020
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| נושאים: | |
| גישה מקוונת: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7444779/ https://ncbi.nlm.nih.gov/pubmed/32200551 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.14284 |
| תגים: |
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