Pharmacovigilance in Neuroscience

[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 ...

Pharmacovigilance 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 ...

Bayesian 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 Nonetheless, in recent years, several approved drugs have been withdrawn from the market because of serious and sometimes fatal side effects.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...

Pharmacovigilance in the 1990s.

Since the thalidomide disaster brought the risks of drug events usually refer to general practitioner contacts, outpatient contacts, hospitalization or deaths. This approach therapy into sharp focus, efforts have been made to establish observational systems for early detection of possible adverse was first mooted by Finney in Edinburgh as far back as 1965 [10], but had to await the advent of po...

Forensic pharmacovigilance.