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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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Detalles Bibliográficos
Autores principales: 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: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4474891/
https://www.ncbi.nlm.nih.gov/pubmed/26090678
http://dx.doi.org/10.1371/journal.pone.0130399