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
Main Authors: 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
Formato: Artigo
Idioma:Inglês
Publicado em: Public Library of Science (PLoS) 2015-01-01
Colecção:PLoS ONE
Acesso em linha:http://europepmc.org/articles/PMC4474891?pdf=render
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