clinical trial

(redirected from Phase III trials)
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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 ?
16 September 2011 - US biopharmaceutical company Trius Therapeutics Inc (NASDAQ:TSRX) said yesterday that it had finalised patient enrollment in the first of the two Phase III trials of tedizolid phosphate in the study of acute bacterial skin and skin structure infections (ABSSSI).
One issue that there appears to be universal agreement on is the importance of participation in clinical trials, specifically randomized phase III trials.
Both agreements mean the company and FDA agree on the design of the Phase III trials to support efficacy claims in new drug application (NDA) submissions.
STOCKHOLM, Sweden -- Biopharma company Biovitrum (STO:BVT), listed on the Stockholm Stock Exchange since September 15, 2006, has entered an agreement with the Uppsala-based biotech company Resistentia Pharmaceuticals AB for process development and manufacturing of the biopharmaceutical substance RES 08 intended for use in clinical phase III trials of Resistentia's new protein-based drug candidate for the treatment of allergy.
Company to Move Forward in Phase III Trials in Stuttering
Nasdaq: SEPR) today announced that it presented a poster of pooled data from Phase III trials of arformoterol tartrate inhalation solution at the 16th Annual Congress of the European Respiratory Society (ERS) in Munich, Germany.
After having successfully completed Phase II clinical trials, Altus had previously planned to initiate Phase III trials for both programs in the second half of this year.
When combining safety data from both Phase III trials, which will be the basis of the proposed product labeling, the incidence of dry mouth observed in SANCTURA XR patients was 10.
A retrospective analysis of SPIRIT I and II phase III trials describing components of Metabolic Syndrome in patients benefiting from Targretin(R).
Earlier this month, the Company reported the completion of enrollment in the first of its two Phase III trials.
NASDAQ: IDEV) today reported that enrollment has been completed in the Company's Phase II trial for pagoclone, in development for stuttering, and the first of its two ongoing Phase III trials for SANCTURA XR.