clinical trial

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Related to Clinical study: Clinical Study Report
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Noun1.clinical trial - a rigorously controlled test of a new drug or a new invasive medical device on human subjects; in the United States it is conducted under the direction of the FDA before being made available for general clinical use
trial, run, test - the act of testing something; "in the experimental trials the amount of carbon was measured separately"; "he called each flip of the coin a new trial"
phase I, phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase II, phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase III, phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA
phase IV, phase IV clinical trial - sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier trials
References in periodicals archive ?
Examples of forward-looking statements contained in this press release include, among others, statements regarding our interpretation of preclinical studies, development plans for our product candidate, including the development of dose forms, the clinical study testing schedule and milestones, the ability to complete enrollment in our clinical studies, interpretation of scientific basis for ganaxolone use, timing for availability and release of data, the safety, potential efficacy and therapeutic potential of our product candidate, arrangements with any potential strategic partners and our expectation regarding the sufficiency of our working capital.
For our KB174 program, we completed enrollment in a dosing study in healthy subjects and continued to progress our clinical study in patients with cirrhosis.
M2 EQUITYBITES-July 5, 2019-NeuroVive Pharmaceutical starts second part of Phase Ia/b clinical study with KL1333
M2 PHARMA-July 5, 2019-NeuroVive Pharmaceutical starts second part of Phase Ia/b clinical study with KL1333
Global Banking News-July 5, 2019-Infant Bacterial Therapeutics reports first patient recruitment in pivotal phase III clinical study
NORDIC BUSINESS REPORT-July 5, 2019-Infant Bacterial Therapeutics reports first patient recruitment in pivotal phase III clinical study
announced that a global Phase III clinical study (Clarity AD/Study 301) of BAN2401, an anti-amyloid beta protofibril antibody, in patients with early Alzheimer's disease has been initiated.
In its correspondence to JHL, the EMA confirmed it agrees with JHL's development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1101 in patients with diffuse large B-cell lymphoma.
Clinical study of the personalized cancer vaccine is anticipated to begin in 2017.
London, United Kingdom, February 17, 2016 --(PR.com)-- Good records management not only has an impact on how effectively an organisation manages its records during the conduct of a clinical study; well-managed clinical study records are critical to demonstrating compliance with GCP and other applicable regulations, as well as supporting regulatory inspections.
Clinical study shows 100% of subjects reported an improvement in skin brightness after 60 days.
Tokyo, Oct 10, 2014 - (JCN) - Nitto Denko Corporation (Nitto) announced the initiation of a phase-1b clinical study in the US started in September 2014, to administer a new anti-fibrosis drug in patients for the assessment of safety and efficacy.

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