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- B18a7031dcca5782c101a53f7de666c65 NCIT_P378 "CDISC-GLOSS" @default.
- B18a7031dcca5782c101a53f7de666c65 type Axiom @default.
- B18a7031dcca5782c101a53f7de666c65 annotatedProperty NCIT_P325 @default.
- B18a7031dcca5782c101a53f7de666c65 annotatedSource NCIT_C142385 @default.
- B18a7031dcca5782c101a53f7de666c65 annotatedTarget "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]" @default.