Drug Safety Resource Center

Whitepapers, Published Research, and other drug safety content
The Complete Guide to GVP Module IX for Signal Management

The Complete Guide to GVP Module IX for Signal Management

This guide is intended to provide a comprehensive overview of GVP IX and discuss how Evidex Signal Management, a next generation pharmacovigilance workflow platform can help organizations detect, track, and resolve safety signal and inquiries in compliance with GVP IX.
PV Software in 2019

White Paper: Pharmacovigilance Software in 2019

Analysis of the PV software market in 2019 including trends and comparisons between legacy vs. next generation software.
A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports

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

Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with millions of potential drug–AE pairs to analyze, the issue of focus is daunting.
A drug safey rating system based on post-marketing costs associated with adverse events and poor patient outcomes

A drug safey rating system based on post-marketing costs associated with adverse events and poor patient outcomes

Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there is an acute need for the development of analytics that reflect drug safety in heterogeneous, real-world populations.
The Weber Effect and FAERS: Analysis of Sixty-Two Drugs Approved from 2006 to 2010

The Weber Effect and FAERS: Analysis of Sixty-Two Drugs Approved from 2006 to 2010

Most of the modern adverse event reporting into FAERS does not follow the pattern described by the ‘Weber Effect'. Modern FAERS reporting has improved greatly over the last decade and will be an increasingly important factor in determining the overall safety profile of FDA approved prescription drugs
Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)

Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)

“Stimulated reporting,” is the concept that public disclosure of a safety issue by the issuance of an FDA alert or warning, or the clustering of adverse event reports triggered by consumer-based “support group” and/or litigation, will result in substantially increased reporting rates for the affected drug. This publication refutes this widely held assumption
Neuropsychiatric adverse effectsof oseltamivir in the FDA Adverse Event Report System, 1999-2012

Neuropsychiatric adverse effectsof oseltamivir in the FDA Adverse Event Report System, 1999-2012

Publications from Roche and a case-control study suggest that there is no evidence, or plausible mechanism of action, to link neuropsychiatric adverseeventst oTamiflu (oseltamivir). Cochrane Collaborators, the BMJ ,and others,however, contend that many of Roche’s data remain unavailable.
A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the Statin drug class

A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the Statin drug class

Cholesterol management drugs known as statins are widely used and often well tolerated; however, a variety of muscle-related side effects can arise. We conducted a review of post-approval muscle and tendon AE reports in association with statin use, to assess differences within the drug class.
Thromboembolic Adverse Events and JAK Inhibitors

Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors

A systematic review of FAERS found elevated reporting for both tofacitinib and ruxolitinib for certain thromboembolic adverse events
Adverse Drug Event Reporting Rates: Comparing FAERS to Clinical Trials

Adverse Drug Event Reporting Rates: Comparing FAERS to Clinical Trials

Compares the rate of adverse drug events (ADEs) for individual drugs from pre-approval clinical trials to post-approval reporting to FDA’s Adverse Event Reporting System (FAERS).

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