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 ?
M2 PHARMA-February 16, 2018-First Patient Enrolled in Mallinckrodt's Safety and Tolerability Study of Skin Substitute
Josef Neu have made an initial evaluation of the topline data of the Phase II study of IBP-9414, finding a similar safety and tolerability profile in the active and placebo groups, the company reported on Monday.
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 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.
Under the first study, the company will investigate the safety and tolerability of single escalating oral doses of d-Methadone to determine the maximum tolerated dose for single drug administration.
M2 EQUITYBITES-January 25, 2013-BioDelivery Sciences completes safety and tolerability trial of BEMA Buprenorphine/Naloxone(C)2013 M2 COMMUNICATIONS http://www.
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.
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