Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source

Y Noguchi, T Tachi, H Teramachi - Briefings in bioinformatics, 2021 - academic.oup.com
Continuous evaluation of drug safety is needed following approval to determine adverse
events (AEs) in patient populations with diverse backgrounds. Spontaneous reporting …

Quantitative signal detection using spontaneous ADR reporting

A Bate, SJW Evans - Pharmacoepidemiology and drug safety, 2009 - Wiley Online Library
Quantitative methods are increasingly used to analyse spontaneous reports. We describe
the core concepts behind the most common methods, the proportional reporting ratio (PRR) …

Detection of drug–drug interactions through data mining studies using clinical sources, scientific literature and social media

S Vilar, C Friedman, G Hripcsak - Briefings in bioinformatics, 2018 - academic.oup.com
Drug–drug interactions (DDIs) constitute an important concern in drug development and
postmarketing pharmacovigilance. They are considered the cause of many adverse drug …

Mining clinical text for signals of adverse drug-drug interactions

SV Iyer, R Harpaz, P LePendu… - Journal of the …, 2014 - academic.oup.com
Background and objective Electronic health records (EHRs) are increasingly being used to
complement the FDA Adverse Event Reporting System (FAERS) and to enable active …

The role of data mining in pharmacovigilance

M Hauben, D Madigan, CM Gerrits… - Expert opinion on …, 2005 - Taylor & Francis
A principle concern of pharmacovigilance is the timely detection of adverse drug reactions
that are novel by virtue of their clinical nature, severity and/or frequency. The cornerstone of …

Perspectives on the use of data mining in pharmacovigilance

J Almenoff, JM Tonning, AL Gould, A Szarfman… - Drug safety, 2005 - Springer
In the last 5 years, regulatory agencies and drug monitoring centres have been developing
computerised data-mining methods to better identify reporting relationships in spontaneous …

A statistical methodology for drug–drug interaction surveillance

GN Norén, R Sundberg, A Bate… - Statistics in …, 2008 - Wiley Online Library
Interaction between drug substances may yield excessive risk of adverse drug reactions
(ADRs) when two drugs are taken in combination. Collections of individual case safety …

Decision support methods for the detection of adverse events in post-marketing data

M Hauben, A Bate - Drug discovery today, 2009 - Elsevier
Spontaneous reporting is a crucial component of post-marketing drug safety surveillance
despite its significant limitations. The size and complexity of some spontaneous reporting …

Review of statistical methodologies for detecting drug–drug interactions using spontaneous reporting systems

Y Noguchi, T Tachi, H Teramachi - Frontiers in pharmacology, 2019 - frontiersin.org
Concomitant use of multiple drugs for therapeutic purposes is known as “polypharmacy
situations,” which has been recognized as an important social problem recently. In …

Practical pharmacovigilance analysis strategies

A Lawrence Gould - Pharmacoepidemiology and drug safety, 2003 - Wiley Online Library
Purpose To compare two recently proposed Bayesian methods for quantitative
pharmacovigilance with respect to assumptions and results, and to describe some practical …