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Preparing for safety issues following drug approval: pre-approval risk management considerations
Risk management plans and risk minimization plans as well as postapproval commitment studies are based on risks identified pre-approval that need to be further characterized or minimized in the postmarketing environment. Although the implementation of these activities are conducted in the postapprov...
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| Autors principals: | , |
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| Format: | Artigo |
| Idioma: | Inglês |
| Publicat: |
SAGE Publications
2013
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| Matèries: | |
| Accés en línia: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4125315/ https://ncbi.nlm.nih.gov/pubmed/25114783 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2042098613498091 |
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