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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...

Ausführliche Beschreibung

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Bibliografische Detailangaben
Hauptverfasser: 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
Format: Artigo
Sprache:Inglês
Veröffentlicht: Public Library of Science (PLoS) 2015-01-01
Schriftenreihe:PLoS ONE
Online-Zugang:http://europepmc.org/articles/PMC4474891?pdf=render
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