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Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks
BACKGROUND: Mechanisms underlying safety events may be heterogeneous and depend on conditions of development and marketing, including the populations studied in clinical trials and the amount of data required for approval, especially under pathways for accelerated access. OBJECTIVE: This study was c...
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| Publicado no: | Pharmaceut Med |
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| Main Authors: | , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer International Publishing
2017
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5629242/ https://ncbi.nlm.nih.gov/pubmed/29056852 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40290-017-0198-2 |
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