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Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project

Individual case safety reports (ICSRs) are a cornerstone in drug safety surveillance. The knowledge on using these data specifically for children is limited. We studied characteristics of pediatric ICSRs reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Pu...

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Détails bibliographiques
Publié dans:PLoS One
Auteurs principaux: de Bie, Sandra, Ferrajolo, Carmen, Straus, Sabine M. J. M., Verhamme, Katia M. C., Bonhoeffer, Jan, Wong, Ian C. K., Sturkenboom, Miriam C. J. M.
Format: Artigo
Langue:Inglês
Publié: Public Library of Science 2015
Sujets:
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC4474891/
https://ncbi.nlm.nih.gov/pubmed/26090678
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1371/journal.pone.0130399
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