منابع مشابه
Challenges and Future Consideration for Pharmacovigilance
There is always a trade-off involved between the advantages and the possible risk with the use of pharmaceuticals. The risk is minimized when medicines of good quality, safety and efficacy are used rationally by an informed health professional and by patients. Pharmacovigilance helps in reducing the risk of harm by ensuring good quality medicines are used appropriately and expectations and conc...
متن کاملAdverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance
Pharmacovigilance plays a consequential role in the surveillance of adverse drug reactions, which is provoked by the drugs used to cure diseases. Adverse drug reactions (ADRs) produce detrimental or undesirable effects to the body after administration of drugs. It has been reported that the number of patients dying because of contrary effects of drugs per year increased upto 2.6-fold. Moreover,...
متن کامل[Pharmacovigilance in clinical trials].
Prema definiciji Svetske zdravstvene organizacije farmakovigilanca je nauka ili skup aktivnosti povezanih sa detekcijom, procenom, razumevanjem i prevencijom neželjenih efekata ili bilo kojih drugih problema povezanih sa upotrebom lekova . Pod farmakovigilancom se, generalno, smatralo postmarketinško praćenje neželjenih efekata lekova u četvrtoj fazi kliničkih istraživanja lekova . Međutim, sa ...
متن کاملPharmacovigilance in perspective.
Pharmacovigilance is more than spontaneous reporting alone, and the evaluation of marketed medicines is more than just pharmacovigilance. The positioning of a drug usually takes place during the years following introduction, when worldwide experience has accumulated. Originally a modest appendix of drug regulation, pharmacovigilance has become a major activity. The provision of the information ...
متن کاملBayesian Methods in Pharmacovigilance
Regulators such as the U.S. Food and Drug Administration have elaborate, multi-year processes for approving new drugs as safe and effective. Nonetheless, in recent years, several approved drugs have been withdrawn from the market because of serious and sometimes fatal side effects. We describe statistical methods for post-approval data analysis that attempt to detect drug safety problems as qui...
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ژورنال
عنوان ژورنال: Drug Safety
سال: 2011
ISSN: 0114-5916
DOI: 10.2165/11586350-000000000-00000