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 PHARMA-August 7, 2019-US FDA Clears Inotrem Investigational New Drug for the Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy
M2 EQUITYBITES-July 8, 2019-Cyxone announces submission of first RA application for clinical phase IIb trial with Rabeximod
Global Banking News-July 8, 2019-Cyxone announces submission of first RA application for clinical phase IIb trial with Rabeximod
Following completion of the Phase II Crohn's study and the Phase IIb induction portion of the ulcerative colitis study, Janssen can elect to enter into an exclusive license arrangement by paying Theravance Biopharma $200 million fee.
NeuroVive Pharmaceutical AB, the mitochondrial medicine company, today announced positive feedback on its requested Scientific Advice (Protocol Assistance) from the European Medicinal agency (EMA), on the NeuroSTAT development plan for treatment of moderate to severe Traumatic Brain Injury (TBI), including the design of its planned Phase IIb proof of concept study.
has met key efficacy endpoints for clinical activity after 24 weeks in a Phase IIb rheumatoid arthritis (RA) study.
NORDIC BUSINESS REPORT-November 7, 2011--Medivir's Irish partner Tibotec to present Phase IIb data on hepatitis C drug candidate(C)2011 M2 COMMUNICATIONS
MultiCell has scheduled a meeting with the MHRA for December 1, 2006, to present the company's clinical development plan for the Phase IIb of MCT-125.
Hematide utilizes Nektar Advanced PEGylation Technology and is in Phase IIb clinical trials for the treatment of anemia.
Tokyo, Japan, Mar 15, 2006 - (JCN) - Taisho Pharmaceutical and Nissan Chemical Industries jointly announced yesterday that the current phase IIb clinical study for NM-702 conducted in the US has demonstrated positive results.
(Cambridge, MA) announced voluntary discontinuation of phase IIb clinical trials of pralnacasan, an oral interleukin-1 beta converting enzyme (ICE) inhibitor, in rheumatoid arthritis.
M2 PHARMA-July 8, 2019-Cyxone announces submission of first RA application for clinical phase IIb trial with Rabeximod