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Publikováno v:
Drug Safety. 45:1529-1538
In 2018, we published the MONARCSi algorithmic decision support tool showing high inter-rater agreement, moderate sensitivity, and high specificity compared with drug-event pairs (DEPs) previously reviewed using current, industry-established approach
MOdified NARanjo Causality Scale for ICSRs (MONARCSi): A Decision Support Tool for Safety Scientists
Publikováno v:
Drug Safety
Introduction Within the field of Pharmacovigilance, the most common approaches for assessing causality between a report of a drug and a corresponding adverse event are clinical judgment, probabilistic methods and algorithms. Although multiple methods
Autor:
Cartic Ramakrishnan, Sujan Perera, Meenakshi Nagarajan, J. T. Fine, Shawman Meireis, Shaun Comfort, Zoe Hudson, Darren Dorrell
Publikováno v:
Drug Safety
Introduction There is increasing interest in social digital media (SDM) as a data source for pharmacovigilance activities; however, SDM is considered a low information content data source for safety data. Given that pharmacovigilance itself operates