Good Signal Detection Practices: Evidence from IMI PROTECT

Electronic Health Data for Postmarket Surveillance: A Vision Not Realized

(2015) Thomas J. Moore et al.   DRUG SAFETY

Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases

(2015) Gianmario Candore et al.   DRUG SAFETY

Performance of Probabilistic Method to Detect Duplicate Individual Case Safety Reports

(2014) Philip Michael Tregunno et al.   DRUG SAFETY

Improved Statistical Signal Detection in Pharmacovigilance by Combining Multiple Strength-of-Evidence Aspects in vigiRank

(2014) Ola Caster et al.   DRUG SAFETY

Bridging Islands of Information to Establish an Integrated Knowledge Base of Drugs and Health Outcomes of Interest

(2014) Richard D. Boyce et al.   DRUG SAFETY

Structured Assessment for Prospective Identification of Safety Signals in Electronic Medical Records: Evaluation in the Health Improvement Network

(2014) S. Cederholm et al.   DRUG SAFETY

Reducing the noise in signal detection of adverse drug reactions by standardizing the background: a pilot study on analyses of proportional reporting ratios-by-therapeutic area

(2014) Birgitta Grundmark et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Quantitative signal detection for vaccines: Effects of stratification, background and masking on GlaxoSmithKline’s spontaneous reports database

(2014) Ziad Zeinoun et al.   Human vaccines & immunotherapeutics

Formalizing MedDRA to support semantic reasoning on adverse drug reaction terms

(2014) Cédric Bousquet et al.   JOURNAL OF BIOMEDICAL INFORMATICS

Predicting potential liver toxicity from phase 2 data: a case study with ximelagatran

(2014) Harry Southworth   STATISTICS IN MEDICINE

Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership

(2013) Paul E. Stang et al.   ANNALS OF INTERNAL MEDICINE

The Development and Evaluation of Triage Algorithms for Early Discovery of Adverse Drug Interactions

(2013) Johanna Strandell et al.   DRUG SAFETY

A conceptual approach to the masking effect of measures of disproportionality

(2013) Francois Maignen et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases

(2013) Francois Maignen et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Vaccine-Based Subgroup Analysis in VigiBase

(2012) Sandra de Bie et al.   DRUG SAFETY

Effect of Competition Bias in Safety Signal Generation

(2012) Antoine Pariente et al.   DRUG SAFETY

Combing signals from spontaneous reports and electronic health records for detection of adverse drug reactions

(2012) Rave Harpaz et al.   JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION

Using Electronic Health Care Records for Drug Safety Signal Detection

(2012) Martijn J. Schuemie et al.   MEDICAL CARE

Multivariate extreme value modelling of laboratory safety data from clinical studies

(2012) Harry Southworth et al.   PHARMACEUTICAL STATISTICS

Electronic healthcare databases for active drug safety surveillance: is there enough leverage?

(2012) Preciosa M. Coloma et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

A shrinkage-based comparative assessment of observed-to-expected disproportionality measures

(2012) Geoffrey Gipson   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Optimization of a quantitative signal detection algorithm for spontaneous reports of adverse events post immunization

(2012) Lionel Van Holle et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership

(2012) Patrick B. Ryan et al.   STATISTICS IN MEDICINE

Terminological Challenges in Safety Surveillance

(2011) Andrew Bate et al.   DRUG SAFETY

Safety surveillance of longitudinal databases: methodological considerations

(2011) G. Niklas Norén et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Comparative effectiveness of individual angiotensin receptor blockers on risk of mortality in patients with chronic heart failure

(2011) Rishi J. Desai et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery

(2011) G Niklas Norén et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

A Decade of Data Mining and Still Counting

(2010) Manfred Hauben et al.   DRUG SAFETY

Validation of Statistical Signal Detection Procedures in EudraVigilance Post-Authorization Data

(2010) Yolanda Alvarez et al.   DRUG SAFETY

An Experimental Investigation of Masking in the US FDA Adverse Event Reporting System Database

(2010) Hsin-wei Wang et al.   DRUG SAFETY

Signal detection of rosuvastatin compared to other statins: data-mining study using national health insurance claims database

(2010) Nam-Kyong Choi et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project

(2010) Preciosa M. Coloma et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD

(2010) Martijn J. Schuemie   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

A potential competition bias in the detection of safety signals from spontaneous reporting databases

(2010) Antoine Pariente et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide

(2009) David D. Dore et al.   CURRENT MEDICAL RESEARCH AND OPINION

Temporal pattern discovery in longitudinal electronic patient records

(2009) G. Niklas Norén et al.   DATA MINING AND KNOWLEDGE DISCOVERY

Effects of Stratification on Data Mining in the US Vaccine Adverse Event Reporting System (VAERS)

(2009) Emily Jane Woo et al.   DRUG SAFETY

Influence of the MedDRA® hierarchy on pharmacovigilance data mining results

(2009) Ronald K. Pearson et al.   INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS

Signal detection for vaccine side effects that have not been specified in advance

(2009) Alexander M. Walker   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Quantitative signal detection using spontaneous ADR reporting

(2009) A. Bate et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?

(2009) Gianluca Trifirò et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Impact of Stratification on Adverse Drug Reaction Surveillance

(2008) Johan Hopstadius et al.   DRUG SAFETY

Mining Unexpected Temporal Associations: Applications in Detecting Adverse Drug Reactions

(2008) Huidong Jin et al.   IEEE TRANSACTIONS ON INFORMATION TECHNOLOGY IN BIOMEDICINE

Adaptation of Bayesian Data Mining Algorithms to Longitudinal Claims Data

(2008) Jeffrey R. Curtis et al.   MEDICAL CARE

A statistical methodology for drug–drug interaction surveillance

(2008) G. Niklas Norén et al.   STATISTICS IN MEDICINE