Signal Detection in EudraVigilance
نویسنده
چکیده
This paper does not present finished work but discusses a current problem faced by the EMEA in detecting when a new safety problem with a marketed pharmaceutical product is emerging. This detection is based on analysis of a very large database of spontaneous reports by healthcare professionals. The mixture of complexity but also known structure within the data appear to call for a combination of formal statistical modeling and data-mining.
منابع مشابه
Screening for adverse reactions in EudraVigilance
4. Screening for adverse reactions in the total population .......................... 6 4.1. Disproportionality methods .................................................................................... 6 4.1.1. Components of the statistical signal detection system based on disproportionality methods ................................................................................................
متن کاملUseful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection
BACKGROUND AND OBJECTIVE Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data sources is essential to enable better detection, strengthening and validation of signals. In this study, we investigated the potential of electronic healthcare records (EHRs) to be used alongsi...
متن کاملFault Detection Method on a Compressor Rotor Using the Phase Variation of the Vibration Signal
The aim of this work is the application of the phase variation in vibration signal for fault detection on rotating machines. The vibration signal from the machine is modulated in amplitude and phase around a carrier frequency. The modulating signal in phase is determined after the Hilbert transform and is used, with the Fast Fourier Transform, to extract the harmonics spectrum in phase. This me...
متن کاملMedication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance
INTRODUCTION Medication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors. OBJECTIVE This study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002-2015 before the release of EU good practice guidance. METHODS Case reports were identified ...
متن کاملRadar Signal Detection in K-distributed Clutter by Pade Approximation
In this paper, two suboptimum detectors are proposed for coherent radar signal detection in K-distributed clutter. Assuming certain values for several initial moments of clutter amplitude, the characteristic function of the clutter amplitude is approximated by a limited series. Using the Pade approximation, it is then converted to a rational fraction. Thus, the pdf of the clutter amplitude is o...
متن کامل