New approaches to drug safety: a pharmacovigilance tool kit
Identifieur interne : 000806 ( Main/Corpus ); précédent : 000805; suivant : 000807New approaches to drug safety: a pharmacovigilance tool kit
Auteurs : Lesley Wise ; John Parkinson ; June Raine ; Alasdair BreckenridgeSource :
- Nature Reviews Drug Discovery [ 1474-1776 ] ; 2009-10.
Abstract
The importance of pharmacovigilance the ongoing assessment of the safety of a marketed medicine has been increasingly appreciated in recent years, owing in part to high-profile safety issues with widely used drugs. In response, strategies to improve the collection, integration and analysis of data related to post-marketing drug safety are being initiated or enhanced. In this article, we summarize the key tools that are available for pharmacovigilance, discuss which might be the most appropriate to use in different situations and consider the future directions of the field.
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DOI: 10.1038/nrd3002
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ISTEX:6D8ACE8929B23E78F5CB89D0F56504786202CCEALe document en format XML
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The research unit provides statistical and pharmacoepidemiological advice to the pharmacovigilance risk assessment group at the MHRA and to industry on safety studies and risk management plans.</note><affiliation>Lesley Wise is Manager of the Pharmacoepidemiology Research Unit in Vigilance and Risk Management of Medicines at the Medicines and Healthcare products Regulatory Agency (MHRA), UK. 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Prior to that, he had 10 years of experience in pharmacoepidemiology and health-care databases at the University of Dundee, UK. He has also worked in the pharmaceutical industry and as a consultant to pharmaceutical, biotechnology and food companies.</affiliation><affiliation>Lesley Wise, John Parkinson, June Raine and Alasdair Breckenridge are at the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK.</affiliation></author><author><persName><forename type="first">June</forename><surname>Raine</surname></persName><note type="biography">June Raine is Director of Post-Licensing at MHRA. She qualified in medicine at Oxford University, UK, and continued with postgraduate research in pharmacology. After working in general medical posts and becoming a Fellow of the Royal College of Physicians, she joined the then Medicines Division of the Department of Health. 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