safety and tolerability
- Guideline or reference source
- ICHE9 Statistical principles for clinical trials
- Definition
- The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and haematology), vital signs, clinical adverse events (diseases, signs and symptoms), and other special safety tests (e.g. ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject.
- Related Term
- adverse effect
- safety
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