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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2015
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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 |