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Lessons learned on the design and the conduct of Post‐Authorization Safety Studies: review of 3 years of PRAC oversight
AIMS: To describe and characterize the first cohort of Post‐Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. METHODS: A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted...
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| Publicado no: | Br J Clin Pharmacol |
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| Main Authors: | , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
John Wiley and Sons Inc.
2016
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5346857/ https://ncbi.nlm.nih.gov/pubmed/27780289 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13165 |
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