Citation

Arlett PR, Kurz X. Drug Discovery Today: Technologies 2011; 8(1): e15-e19.

Copyright

(Copyright © 2011)

DOI

10.1016/j.ddtec.2011.03.003

PMID

unavailable

Abstract

Until recently, pharmacovigilance was mainly based on spontaneous reports, which provide low evidence of risks associated with medicines. Today, the importance of the full spectrum of the evidence hierarchy is recognised. This article reviews new approaches and data sources used in pharmacovigilance and shows that individual case safety reports, observational data, clinical trials and meta-analyses have unique characteristics that complement each other for the overall benefit-risk evaluation of medicines. © 2011 Elsevier Ltd. All rights reserved.

Language: en

Keywords

human; suicide; case study; review; anticonvulsive agent; antidepressant agent; heart infarction; drug safety; methodology; information processing; drug efficacy; meta analysis; risk benefit analysis; drug utilization; drug surveillance program; antibiotic agent; liver injury; calcium channel blocking agent; neoplasm; hip fracture; observational study; Bayes theorem; beta 2 adrenergic receptor stimulating agent; influenza vaccine; clinical trial (topic); public-private partnership; study design; influenza A (H1N1)