Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility

Author:

Muñoz Monica A.ORCID,Dal Pan Gerald J.ORCID,Wei Yu-Jung JennyORCID,Delcher ChrisORCID,Xiao HongORCID,Kortepeter Cindy M.ORCID,Winterstein Almut G.ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference26 articles.

1. Lester J, Neyarapally GA, Lipowski E, Graham CF, Hall M, Dal Pan G. Evaluation of FDA safety-related drug label changes in 2010. Pharmacoepidemiol Drug Saf. 2013;22(3):302–5.

2. Ishiguro C, Hall M, Neyarapally GA, Dal Pan G. Post-market drug safety evidence sources: an analysis of FDA drug safety communications. Pharmacoepidemiol Drug Saf. 2012;21(10):1134–6.

3. FDA Adverse Event Reporting System (FAERS) Public Dashboard. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 6 Dec 2019.

4. Duggirala, HJ, Tonning JM, Smith E, Bright RA, Baker JD, Ball R, et al. Data mining at FDA. http://www.fda.gov/downloads/ScienceResearch/DataMiningatFDA/UCM443675.pdf. Accessed 28 Nov 2019.

5. Bergvall T, Noren GN, Lindquist M. vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf. 2014;37(1):65–77.

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