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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Publicado en:PLoS One
Main Authors: 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.
Formato: Artigo
Idioma:Inglês
Publicado: Public Library of Science 2015
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Research Article
Acceso en liña: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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