While discussions continue about the precise role of data mining in drug safety, there can be little doubt that data mining algorithms have established themselves as a component of the pharmacovigilance “tool-kit”. The drug safety community should facilitate research into the development and testing of novel data mining and statistical algorithms that match the importance and complexity of the ...

The UK Drug Utilization Research Group's (DURG) Regional Meeting 'New Horizons: Pharmacovigilance' was hosted by the Drug Safety Research Unit (DSRU) at Southampton on 19 May 2000. Opening the meeting, Dr Keith Beard, UK DURG chairman, welcomed delegates and speakers and thanked the DSRU team for hosting the meeting. With reference to the theme of the meeting - new horizons in pharmacovigilance...

The introduction in clinical practice of pharmaceutical products known as biosimilars, as part of a more complex series of progress in the field of biological drugs, represents an excellent therapeutic resource. A biosimilar drug is a biological/biotechnological drug that is highly similar to an approved reference biologic product. Given their complexity, biosimilars require attention and a con...

The Therapeutic Goods Administration is strengthening pharmacovigilance, but strategies to encourage the conduct of pharmacoepidemiological research in Australia are needed.

detection of adverse drug reactions (adrs) in hospitals provides an important measure of the burden of drug related morbidity on the healthcare system. spontaneous reporting of adrs is scare and several obstacles to such reporting have been identified formerly. this study aimed to determine the role of clinical pharmacy residents in adr reporting within a hospital setting.clinical pharmacy resi...

d Q-T interval have been reported Lancer 1998;352:162-3. 5 Waller PC, Coulson RA, Wood SM. Regulatory pharmacovigilance in the United Kingdom: current principles and practice. Pharnracoepidemwl Drug Safety 1996;5:363-75. 6 Li Wan Po A, Zhang WY. What lessons can be rk reiterates our learnt from withdrawal of mibefradil from the market? Lancer 1998;351:1829-30. with 7 Lawson DH. Pharmacovigilanc...

Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Counc...

Introduction: The primary objective of this study is to assess the knowledge, attitude and awareness adverse drug reaction reporting process among Indian medical undergraduates in a tertiary care teaching hospital. Material Methods: This cross sectional questionnaire based on 250 graduates. Phase III – Part 1 2 Medical Undergraduates at Trichy SRM College Hospital & Research Centre for next 3 m...

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 ...