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.
References in periodicals archive ?
United States-based Impel NeuroPharma has enrolled its last patient in the 'STOP-301' (Safety and Tolerability of POD-DHE) trial, an open-label Phase three, multi-use, long-term safety and tolerability trial of INP104 intended for the treatment of acute migraine, it was reported yesterday.
announced topline results from the first pivotal Phase 3 clinical trial evaluating the efficacy, safety and tolerability of inclisiran to decrease LDL-cholesterol, or LDL-C, through twice-yearly dosing.
This ongoing Phase 1/2a multicentre, open-label study is expected to take place at 15 sites in the US, UK and Israel in two parts to evaluate the safety and tolerability of AGI-134, given both as monotherapy and in combination with an immune checkpoint inhibitor, in solid tumours.
The NDA filing is based on the successful completion of four clinical trials two pivotal studies, ACHIEVE I and ACHIEVE II, which demonstrated the efficacy, safety and tolerability of ubrogepant, as well as two additional safety studies.
Once the recommended Phase II dose has been identified, the second part of the study will evaluate the safety and tolerability of birinapant in combination with KEYTRUDA in several cohorts.
A company medical advisor said the safety and tolerability of intrathecal and intramuscular injections "appears to be excellent."
(Japan) announced the recent publication of an original research study on the "Safety and Tolerability of Dr.
The company said its hepatitis C drug candidate showed positive "proof-of-concept" results, while meeting safety and tolerability goals in an early-stage study.
Preclinical and clinical data to date suggests superior safety and tolerability, as well as increased potency versus MTX, currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases.
The primary study endpoints are the safety and tolerability of single and repeated doses of inhaled Ostabolin-C.
Safety and tolerability were comparable for the two doses, said Dr.
Safety and tolerability data on 516 participants evaluated so far show that the 213 patients in the 3[micro]g/kg per week group had a higher rate of dose reductions (33%, vs.
Full browser ?