clinical trial

(redirected from Phase IIb)
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Related to Phase IIb: phase 2 clinical trial, double dummy
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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 ?
M2 EQUITYBITES-July 11, 2017-IDSMB gives positive review for Neovacs' Phase IIb clinical trial of IFNalpha Kinoid in lupus
M2 PHARMA-July 11, 2017-IDSMB gives positive review for Neovacs' Phase IIb clinical trial of IFNalpha Kinoid in lupus
SeeNews) - Jul 1, 2013 - Belgian biotechnology firm Galapagos (EBR:GLPG) said today the first rheumatoid arthritis (RA) patients had been screened to take part in the Phase IIb clinical trial with the GLPG0634 candidate drug.
Hematide utilizes Nektar Advanced PEGylation Technology and is in Phase IIb clinical trials for the treatment of anemia.
Specifically, the company's development partner GlaxoSmithKline (GSK) has observed elevated liver function test values (AST, ALT and total bilirubin) in the recent Phase IIb studies conducted in North America and Europe.
Ablynx (EBR: ABLX) has said the results from its Phase IIb RA combination study of its anti-IL-6R Nanobody vobarilizumab support the move to advance vobarilizumab into Phase III development, the company announced on Thursday.
SeeNews) - Jun 13, 2013 - Belgian biopharmaceuticals company UCB (EBR:UCB) announced today new data from an open-label extension of its Phase IIb study with epratuzumab for the treatment of systemic lupus erythematosus (SLE).
TSX: MGI; OTC: MGIFF), a clinical-stage developer of drugs for infectious and degenerative diseases, has initiated enrollment in a Phase IIb combination therapy clinical trial of celgosivir (MX-3253), supported in part through an agreement with Schering-Plough.
M2 PHARMA-December 21, 2015-Minerva reaches enrollment target in Phase IIb trial of MIN-101 for schizophrenia
M2 EQUITYBITES-December 21, 2015-Minerva reaches enrollment target in Phase IIb trial of MIN-101 for schizophrenia