" /> Adverse Drug Reaction - CISMeF





Preferred Label : Adverse Drug Reaction;

NCIt synonyms : ADR;

NCIt related terms : adverse drug experience; adverse drug reaction (ADR);

NCIt definition : Any detrimental or unintended response associated with the use of a medication in humans.;

Alternative definition : CDISC-GLOSS: Any noxious and unintended response associated with the use of a drug in humans. NOTE: 1. Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. 2. Pre-approval: an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility. 3. FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, whether or not considered to be drug-related. CDISC recognizes that current usage incorporates the concept of causality. [WHO Technical Report 498(1972); ICH E2A];

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04/05/2024


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