safety profile

How is Causality Determined?

Determining causality involves assessing whether there is a direct link between the intervention and the adverse event. This is often done using criteria such as the Bradford Hill criteria, which include factors like strength of association, consistency of findings, temporality, and biological plausibility. Statistical methods and pharmacovigilance databases are also used to identify potential causal relationships.

Frequently asked queries:

What is a Safety Profile?
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