Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.
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 testing to assess design, performance, and user satisfaction with the tool.
Author(s): Sorbello, Alfred, Ripple, Anna, Tonning, Joseph, Munoz, Monica, Hasan, Rashedul, Ly, Thomas, Francis, Henry, Bodenreider, Olivier
DOI: 10.4338/ACI-2016-11-RA-0188