safety and tolerabilityJoe Segen2016-12-14T15:16:57+00:00
safety and tolerability
Definition A self-explanatory term for a clinical trial phrase of art for two key components of medical product evaluation, which are unrelated to a device’s or drug’s efficacy, and typically assessed during a first-in-human trial.
(1) Safety–risk to the subject/patient’s health, usually assessed by laboratory testing–e.g., chemistry and haematology, physical examination–vital signs, adverse events and other tests–e.g., EKG, fundoscopy, etc, and
(2) Tolerability–the degree to which overt adverse effects can be tolerated by the subject/patient.