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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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Detalhes bibliográficos
Publicado no: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 em: Public Library of Science 2015
Assuntos:
Acesso em linha: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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