The Importance of Pharmacovigilance¶
World Health Organization. (2002). The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Domain-specific¶
- Idiosyncratic Reaction
- The defining clinical-epidemiological consequence is that idiosyncratic reactions are the structural reason pharmacovigilance exists: standard randomised clinical trials, powered to detect average treatment effects in populations of hundreds to thousands, will routinely miss reactions whose incidence is 1 in 10,000 to 1 in 100,000 exposures
This sourceStates that rare yet serious drug reactions, such as one in five thousand exposures, may go undetected before registration and are the reason post-marketing pharmacovigilance is required.
Supported in partVerified against a saved copy of the source
“There is a possibility that rare yet serious adverse events (such as those occurring with a frequency of, say, one in five thousand) will not be detected in the pre-registration development of the drug.”
- The defining clinical-epidemiological consequence is that idiosyncratic reactions are the structural reason pharmacovigilance exists: standard randomised clinical trials, powered to detect average treatment effects in populations of hundreds to thousands, will routinely miss reactions whose incidence is 1 in 10,000 to 1 in 100,000 exposures
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Read against the text for 1 of 1 citation: 1 supported in part. Each verdict is shown under its citation below, with what in the work backs the sentence.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
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Registry ID ref:65592463a52c · see in the full table