Research Topics
| I Ralph EdwardsSummaryAffiliation: WHO Collaborating Centre for International Drug Monitoring Country: Sweden Publications
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Detail Information
Publications
Considerations on causality in pharmacovigilanceI Ralph Edwards
Senior Advisor and Emeritus Director of the Uppsala Monitoring Centre, Uppsala, Sweden E mail
Int J Risk Saf Med 24:41-54. 2012..Other areas of society are concerned with the process of causal inference, and this is especially true in legal cases in which judgements are made on possible personal injury by drugs...
Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibaseI Ralph Edwards
The WHO Foundation Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre UMC, Uppsala, Sweden
Drug Saf 30:515-25. 2007....
The future of pharmacovigilance: a personal viewI Ralph Edwards
The WHO Foundation Collaborating Centre for International Drug Monitoring, Stora Torget 3, Uppsala, Sweden
Eur J Clin Pharmacol 64:173-81. 2008
The WHO World Alliance for Patient Safety: a new challenge or an old one neglected?I Ralph Edwards
The Uppsala Monitoring Centre, Uppsala, Sweden
Drug Saf 28:379-86. 2005..One thing is certain, working together both systems will improve patient care, but without cooperation more bureaucracy will take valuable health professional time with a lesser result...
Intuition, evidence, and safetyI Ralph Edwards
The WHO Foundation Collaborating Centre for International Drug Monitoring, Uppsala, S-7530, Sweden
Lancet 364:387. 2004
Withdrawing drugs: nefazodone, the start of the latest sagaI Ralph Edwards
Uppsala Monitoring Centre, S-753 20, Uppsala, Sweden
Lancet 361:1240. 2003
Impact of stratification on adverse drug reaction surveillanceJohan Hopstadius
Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Drug Saf 31:1035-48. 2008....
Signal selection and follow-up in pharmacovigilanceRonald H B Meyboom
The Uppsala Monitoring Centre, Uppsala, Sweden
Drug Saf 25:459-65. 2002..In the future a combination of quantitative and qualitative criteria may be incorporated in automated signal detection...
Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBaseKristina Star
Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Drug Saf 34:415-28. 2011..As a first step towards implementing routine screening of safety issues specifically related to children at the Uppsala Monitoring Centre, this study was performed to explore reporting patterns of adverse reactions in children...
Reporting patterns indicative of adverse drug interactions: a systematic evaluation in VigiBaseJohanna Strandell
Uppsala Monitoring Centre, Uppsala, Sweden
Drug Saf 34:253-66. 2011..Additionally, too little attention has been given to the potential value of the detailed content of ICSRs for improved adverse drug interaction surveillance...
A statistical methodology for drug-drug interaction surveillanceG Niklas Norén
WHO Collaborating Centre for International Drug Monitoring in Uppsala, Uppsala, Sweden
Stat Med 27:3057-70. 2008..As always in the analysis of ICSRs, the clinical validity of hypotheses raised with the proposed method must be further reviewed and evaluated by subject matter experts...
Assessing the impact of drug safety signals from the WHO database presented in 'SIGNAL': results from a questionnaire of National pharmacovigilance CentresMalin Stahl
Uppsala Monitoring Centre, Uppsala, Sweden
Drug Saf 26:721-7. 2003..Summary case data are reviewed by experts on the UMC's review panel and the signals are presented to the Programme members in the restricted circulation document entitled 'SIGNAL'...
Extending the methods used to screen the WHO drug safety database towards analysis of complex associations and improved accuracy for rare eventsG Niklas Norén
The WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Stat Med 25:3740-57. 2006..The accuracy of the proposed credibility intervals is evaluated through comparison to precise Monte Carlo simulations. In addition, we propose a Mantel-Haenszel-type adjustment to control for suspected confounders...
Rhabdomyolysis a result of azithromycin and statins: an unrecognized interactionJohanna Strandell
The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Br J Clin Pharmacol 68:427-34. 2009..The aim was to examine all reports including rhabdomyolysis-azithromycin and statins in VigiBase to assess if the data were suggestive of an interaction...
Pneumonia following antipsychotic prescriptions in electronic health records: a patient safety concern?Kristina Star
Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring WHO CCIDM, Uppsala Monitoring Centre, Research Department, Box 1051, Uppsala, 75140, Sweden
Br J Gen Pract 60:e385-94. 2010..In screening the Intercontinental Medical Statistics (IMS) Health Disease Analyzer database of GP records from the UK, an increased registration of pneumonia subsequent to the prescription of some antipsychotic medicines was identified...
Rosuvastatin and the statin wars--the way to peaceRonald H B Meyboom
Department of Pharmacoepidemiology, Faculty of Pharmaceutical Sciences, Utrecht University, 3508 TB Utrecht, Netherlands
Lancet 364:1997-9. 2004
Dose variations associated with formulations of NSAID prescriptions for children: a descriptive analysis of electronic health records in the UKKristina Star
Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Drug Saf 34:307-17. 2011..NSAIDs, particularly ibuprofen, are commonly prescribed for children but there is limited published research on real-life prescribed doses for this class of drugs...
A data mining approach for signal detection and analysisAndrew Bate
The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Drug Saf 25:393-7. 2002..Quantitatively unexpectedly strong relationships in the data are highlighted relative to general reporting of suspected adverse effects; these associations are then clinically assessed...
Drug-drug interactions - a preventable patient safety issue?Johanna Strandell
Br J Clin Pharmacol 65:144-6. 2008
A bayesian recurrent neural network for unsupervised pattern recognition in large incomplete data setsRoland Orre
Mathematical Statistics, Stockholm University, SE 106 91 Stockholm, and NeuroLogic Sweden AB, Solna, Sweden
Int J Neural Syst 15:207-22. 2005..With its better scaling properties, the neural network is a promising tool for unsupervised pattern recognition in huge databases of incomplete observations...
What are the real lessons from Vioxx?I Ralph Edwards
Drug Saf 28:651-8. 2005
The challenge of effectively communicating patient safety informationBruce Hugman
Expert Opin Drug Saf 5:495-9. 2006....
What is drug safety?: celebrating 20 years of the Drug Safety journalI Ralph Edwards
Drug Saf 29:461-5. 2006
TNF-alpha inhibitors and leukaemia: international pharmacovigilance reportsRonald H B Meyboom
Drug Saf 31:445-7. 2008
Guidelines for submitting adverse event reports for publicationWilliam N Kelly
William N Kelly Consulting, Inc, Oldsmar, Florida 34677, USA
Pharmacoepidemiol Drug Saf 16:581-7. 2007..They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events...
Labelling and 'Dear Doctor' letters: are they noncommittal?A C Kees van Grootheest
Netherlands Pharmacovigilance Centre Lareb, s Hertogenbosch, The Netherlands
Drug Saf 25:1051-5. 2002..The dispensing pharmacist can play an important role in the implementation of warnings and contraindications...
Standardized assessment of adverse events in rheumatology clinical trials: summary of the OMERACT 7 drug safety module updateMarissa N D Lassere
Department of Rheumatology, University of New South Wales, St George Hospital, Belgrave Street, Kogarah, Sydney, 2127 NSW, Australia
J Rheumatol 32:2037-41. 2005..Most found the patient checklist attractive, particularly if the patient instrument was shown to be reliable and valid. Finally, a future research agenda was discussed...
