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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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Autori principali: Dieck, Gretchen S., Sharrar, Robert G.
Natura: Artigo
Lingua:Inglês
Pubblicazione: SAGE Publications 2013
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Accesso online: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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