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Harnessing Scientific Literature Reports for Pharmacovigilance: Prototype software analytical tool development and usability testing

OBJECTIVES: We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers’ capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability te...

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Detalles Bibliográficos
Autores principales: Sorbello, Alfred, Ripple, Anna, Tonning, Joseph, Munoz, Monica, Hasan, Rashedul, Ly, Thomas, Francis, Henry, Bodenreider, Olivier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Schattauer 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5373771/
https://www.ncbi.nlm.nih.gov/pubmed/28326432
http://dx.doi.org/10.4338/ACI-2016-11-RA-0188