Causality Assessment

Causality assessment of ADRs is a method used for estimating the strength of relationship between drugs exposure and occurrence of adverse reactions. Causality assessment of ADRs may be undertaken by clinicians, academics, the pharmaceutical industry and regulators, and in different settings, including clinical trials. At an individual level, health-care providers assess causality informally when dealing with ADRs in patients to make decisions regarding future therapy. Many regulatory authorities assess spontaneous ADR reports, where causality assessment can help in signal detection and risk–benefit decisions regarding medicines, using formal Causality Assessment to aid in this process.



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