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 ?
The data show that ADX71149 met the primary objectives of safety and tolerability.
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.
As the improved safety and tolerability of CH-1504 is expected to be a significant advantage over MTX, the trial will also compare a cluster of gastrointestinal system related adverse events, such as nausea, vomiting, and diarrhea, frequently seen with MTX use as well as closely monitor the results of standard liver function tests across dose groups.
and Europe to evaluate the efficacy, dose response, safety and tolerability of Reverset in treatment- experienced human immunodeficiency virus (HIV) infected patients who are failing their current treatment regimens.
The Company is currently conducting a safety and tolerability study in Alzheimer's patients under a U.
The favorable safety and tolerability profile observed for arimoclomol in our recent Phase IIa ALS trial, combined with previous and recent animal toxicology results, suggests that we may be able to safely increase the dose without causing significant side effects.
The primary endpoints of this randomized, double-blind, multiple ascending dose Phase 2a trial are to assess the safety and tolerability of PRX-03140 administered alone and in combination with donepezil, and to measure the effect of PRX-03140 on quantitative electroencephalograms (qEEGs), including the alpha/theta ratio (a biomarker which indicates an effect on the cholinergic system in the brain).
This study will evaluate this compound as an add-on therapy in patients with refractory epilepsy for its safety and tolerability as well as provide a preliminary assessment of its effectiveness for seizures and its actions on mood and memory.
The randomized, placebo-controlled four-week Phase 2 trial was designed to assess Traficet-EN's safety and tolerability among Crohn's patients.
Preliminary safety and tolerability data from a recently completed single ascending dose Phase 1 trial in healthy adult male and female volunteers indicated that single doses of PRX-07034 were well-tolerated up to 2500 mg, the highest dose tested.
Full browser ?