منابع مشابه
Role of Pharmacovigilance on Vaccines Control*
The pharmacovigilance of vaccines is defined as the science and activities relating to the detection, assessment, understanding, prevention and communication of adverse events of immunization, or any other vaccine, or issues related with immunization. The strengthening of pharmacovigilance is very important in every country because it helps professional health care workers to avoid the problems...
متن کاملSafety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine Pharmacovigilance Practices Sufficient?
The current paradigm of vaccine pharmacovigilance includes three stages: signal detection, development of a causality hypothesis, and testing of the causality hypothesis [1]. Signal detection in the postmarketing setting largely relies on spontaneous reports of adverse events (AEs) following immunization (AEFI) and literature case reports. The development of a causality hypothesis involves an a...
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 Nonetheless, in recent years, several approved drugs have been withdrawn from the market because of serious and sometimes fatal side effects.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: Indian Journal of Pharmacology
سال: 2010
ISSN: 0253-7613
DOI: 10.4103/0253-7613.64488