How pharmacoepidemiology networks can manage distributed analyses to improve replicability and transparency and minimize bias [PDF]
Several pharmacoepidemiology networks have been developed over the past decade that use a distributed approach, implementing the same analysis at multiple data sites, to preserve privacy and minimize data sharing.
Brown, Jeffrey S. +5 more
core +2 more sources
Pharmacovigilance of Biosimilars [PDF]
In lieu of an abstract, here is the article\u27s first paragraph: Biotech industry forms the backbone of the current pharmaceutical products. Seven out of top ten anticipated drugs of the industry in 2014 will be biologics [1].
Chablani, Lipika
core +2 more sources
Linked health data for pharmacovigilance in children : Perceived legal and ethical issues for stakeholders and data guardians [PDF]
Peer reviewedPublisher ...
Bond, Christine M +4 more
core +2 more sources
An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy [PDF]
Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations.
Blackburn, SCF +11 more
core +7 more sources
Evaluation of Pharmacovigilance System in Iran [PDF]
BackgroundEvaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems ...
Malahat Khalili +6 more
doaj +1 more source
Background Pharmacovigilance in China has experienced rapid development in the past 30 years. The implementation of Good Pharmacovigilance Practice in China since the end of 2021 heralds a new era of pharmacovigilance affairs, which puts forward higher ...
Yalan Tang +4 more
doaj +1 more source
Introduction In randomised controlled trials (RCTs), bleeding outcomes are often assessed using definitions provided by the International Society on Thrombosis and Haemostasis (ISTH).
Alexander Hartenstein +5 more
doaj +1 more source
Bayesian model selection in logistic regression for the detection of adverse drug reactions [PDF]
Motivation: Spontaneous adverse event reports have a high potential for detecting adverse drug reactions. However, due to their dimension, exploring such databases requires statistical methods.
Marbac, Matthieu +2 more
core +3 more sources
Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
A Bate +53 more
core +4 more sources
The promotion of data sharing in pharmacoepidemiology [PDF]
This article addresses the role of pharmacoepidemiology in patient safety and the crucial role of data sharing in ensuring that such activities occur. Against the backdrop of proposed reforms of European data protection legislation, it considers whether ...
Sethi, Nayha
core +1 more source

