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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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Autori principali: Sandra de Bie, Carmen Ferrajolo, Sabine M J M Straus, Katia M C Verhamme, Jan Bonhoeffer, Ian C K Wong, Miriam C J M Sturkenboom, GRiP network
Natura: Artigo
Lingua:Inglês
Pubblicazione: Public Library of Science (PLoS) 2015-01-01
Serie:PLoS ONE
Accesso online:http://europepmc.org/articles/PMC4474891?pdf=render
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