Methods A random sample of 50 reports from VigiBase was evaluated by an expert
physician, without access to previously recorded causality assessments. Each narrative was …

We Need? not new. Over the past few years, many others have commented on the value of
case reports in journals The information we need to make a reliable asand their place in …

Background: Case reports of suspected adverse drug reactions (ADRs) are common in the
biomedical literature. Standards for authors and editors for writing, submitting and publishing …

Much of pharmacovigilance starts with the individual case report. The more detailed its
description, the better it supports our causality assessment. The more explicitly it conveys …

Aggregate reporting involves preparation and submission of safety reports for a given
medicinal product to worldwide regulatory agencies and constitutes an essential part of …

This article, which encourages physicians to publish case reports of adverse drug reactions
(ADRs), is a review of how well-documented published case reports have contributed to …

Background/Introduction: Spontaneous adverse event (AE) reports normally have missing
data and are often insufficient to perform a proper causality assessment. Follow up …

Purpose. Pharmaceutical postmarketing surveillance includes evaluation of reported
adverse events and published case reports. We sought to evaluate the quality of case …

Purpose: A previous study of cases published approximately 10–30 years ago reveals that
substantial improvement in the quality of adverse drug reaction (ADR) case reports is …

Publication of case reports describing suspected adverse effects of drugs and medical
products that include herbal and complementary medicines, vaccines and other biologicals …