safety and tolerability

safety and tolerability

The clinical trial term for two key aspects of medical product evaluation:
(1) Safety—risk to the subject/patient, usually assessed in by laboratory testing (e.g., clinical chemistry and haematology), physical examination (vital signs), clinical adverse events and other tests (e.g., ECGs, ophthalmology); and
(2) Tolerability—which represents the degree to which overt adverse effects can be tolerated by the subject/patient.