Sources of Safety Data and Statistical Strategies for Design and Analysis

Zero-inflated Poisson model based likelihood ratio test for drug safety signal detection

(2016) Lan Huang et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

Extended likelihood ratio test-based methods for signal detection in a drug class with application to FDA’s adverse event reporting system database

(2016) Yueqin Zhao et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance

(2015) I. R. Silva et al.   BIOMETRICS

Electronic Health Data for Postmarket Surveillance: A Vision Not Realized

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

Use of data mining at the Food and Drug Administration

(2015) Hesha J Duggirala et al.   JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION

Exploring the FDA Adverse Event Reporting System to Generate Hypotheses for Monitoring of Disease Characteristics

(2014) H Fang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Commonality of Drug-associated Adverse Events Detected by 4 Commonly Used Data Mining Algorithms

(2014) Toshiyuki Sakaeda et al.   International Journal of Medical Sciences

Group sequential method for observational data by using generalized estimating equations: application to Vaccine Safety Datalink

(2014) Andrea J. Cook et al.   JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES C-APPLIED STATISTICS

Likelihood ratio based tests for longitudinal drug safety data

(2014) Lan Huang et al.   STATISTICS IN MEDICINE

Using real-world healthcare data for pharmacovigilance signal detection – the experience of the EU-ADR project

(2014) Vaishali K Patadia et al.   Expert Review of Clinical Pharmacology

Postmarketing Safety Surveillance

(2013) Preciosa M. Coloma et al.   DRUG SAFETY

Likelihood Ratio Test-Based Method for Signal Detection in Drug Classes Using FDA's AERS Database

(2013) Lan Huang et al.   Journal of Biopharmaceutical Statistics

Drug safety data mining with a tree-based scan statistic

(2013) Martin Kulldorff et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Statistical performance of group sequential methods for observational post-licensure medical product safety surveillance: A simulation study

(2013) Andrea Cook et al.   Statistics and Its Interface

Vaccine adverse event text mining system for extracting features from vaccine safety reports

(2012) Taxiarchis Botsis 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

Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot

(2012) Andrea J. Cook et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

When to publish measures of disproportionality derived from spontaneous reporting databases?

(2011) Anthonius de Boer   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database

(2011) Jean-Louis Montastruc et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A Likelihood Ratio Test Based Method for Signal Detection With Application to FDA’s Drug Safety Data

(2011) Lan Huang et al.   JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION

Methods for observational post-licensure medical product safety surveillance

(2011) Jennifer C Nelson et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance

(2011) Martin Kulldorff et al.   Sequential Analysis-Design Methods and Applications

Quantitative signal detection using spontaneous ADR reporting

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

Adaptation of Bayesian Data Mining Algorithms to Longitudinal Claims Data

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