Evaluation of quantitative signal detection in EudraVigilance for orphan drugs: possible risk of false negatives
Different strategies have been studied to allow a better characterization of the safety profile of orphan drugs soon after their approval. At the end of the development phases only few data are available because of the small number of subjects exposed to an orphan medicine for the treatment of rare...
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SAGE Publishing,
2019-10-01T00:00:00Z.
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