Development of a multivariate prediction model to identify individual case safety reports which require clinical review
Sign Up to like & getrecommendations! Published in 2022 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.5553
Abstract: The number of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases are rapidly increasing worldâwide. The majority of ICSRs at the Netherlands Pharmacovigilance Centre Lareb is reviewed manually to identify potential signal triggering reports (PSTR)… read more here.
Keywords: development multivariate; safety; individual case; case safety ... See more keywords
Identification of Substandard Medicines via Disproportionality Analysis of Individual Case Safety Reports
Sign Up to like & getrecommendations! Published in 2017 at "Drug Safety"
DOI: 10.1007/s40264-016-0499-5
Abstract: IntroductionThe distribution and use of substandard medicines (SSMs) is a public health concern worldwide. The detection of SSMs is currently limited to expensive large-scale assay techniques such as high-performance liquid chromatography (HPLC). Since 2013, the… read more here.
Keywords: substandard medicines; individual case; disproportionality analysis; analysis ... See more keywords
Why Are We Still Creating Individual Case Safety Reports?
Sign Up to like & getrecommendations! Published in 2018 at "Clinical therapeutics"
DOI: 10.1016/j.clinthera.2018.10.012
Abstract: The history of drug safety monitoring, or pharmacovigilance, has been an interesting one. Despite many and ongoing changes, it has typically been characterized by a rather slow-moving and reactive progression. Pharmacovigilance has always lagged behind… read more here.
Keywords: creating individual; individual case; safety reports; safety ... See more keywords