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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...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2017
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629242/ https://www.ncbi.nlm.nih.gov/pubmed/29056852 http://dx.doi.org/10.1007/s40290-017-0198-2 |