Signal Detection in Pharmacovigilance
Toxic signal detection (SD) involves data mining of large PV databases. The WHO defines a toxic signal as: “Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously” . Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and quality of the information.
The Individual Case Safety Reports (ICSRs) in the databases are collected and converted into structured format, and finally statistical methods were applied to calculate an actual measure of signals. Various methods, appropriate for analyzing a large number of reports, are used for SD calculations. Finally a statistically significant signal of a given drug associated with a given toxicity is established as a toxic signal that is worthy of further investigation (qualititative analysis).
The SD is a vital and essential part of drug use and surveillance information. With the help of SD, the authorities and practitioners can easily minimize the number of unexpected serious adverse events and unwanted drug withdrawals.
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Famous quotes containing the word signal:
“Perhaps having built a barricade when you’re sixteen provides you with a sort of safety rail. If you’ve once taken part in building one, even inadvertently, doesn’t its usually latent image reappear like a warning signal whenever you’re tempted to join the police, or support any manifestation of Law and Order?”
—Jean Genet (1910–1986)