A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports

How Good Is “Evidence” from Clinical Studies of Drug Effects and Why Might Such Evidence Fail in the Prediction of the Clinical Utility of Drugs?

(2015) Huseyin Naci et al.   Annual Review of Pharmacology and Toxicology

Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles

(2015) Eve Tang et al.   BMC Medicine

Signal detection in FDA AERS database using Dirichlet process

(2015) Na Hu et al.   STATISTICS IN MEDICINE

Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence

(2015) Joanna Le Noury et al.   BMJ-British Medical Journal

Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence

(2015) Joanna Le Noury et al.   BMJ-British Medical Journal

Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration

(2015) Paul Ma et al.   JAMA Internal Medicine

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

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

An Application of Targeted Maximum Likelihood Estimation to the Meta-Analysis of Safety Data

(2013) Susan Gruber et al.   BIOMETRICS

Data Mining of the Public Version of the FDA Adverse Event Reporting System

(2013) Toshiyuki Sakaeda et al.   International Journal of Medical Sciences

Caution in making inferences from FDA's Adverse Event Reporting System

(2012) M. Auerbach et al.   AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

Data-Driven Prediction of Drug Effects and Interactions

(2012) N. P. Tatonetti et al.   Science Translational Medicine

Ethical Issues in New Drug Prescribing

(2011) Lindsay W. Cole et al.   Journal of Bioethical Inquiry

An Evaluation of Three Signal-Detection Algorithms Using a Highly Inclusive Reference Event Database

(2009) Alan M. Hochberg et al.   DRUG SAFETY

Quantitative signal detection using spontaneous ADR reporting

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