Regeneron, Sanofi initiates clinical trial in Kevzara to treat COVID-19
Regeneron Pharmaceuticals and Sanofi have started a clinical programme evaluating Kevzara (sarilumab) in patients hospitalized with severe coronavirus (COVID-19) infection. Kevzara is... Read More
AstraZeneca’s Forxiga gets EMA positive opinion for DECLARE-TIMI 58 cardiovascular outcomes data
AstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European... Read More
What is an open-label trial?
Open-label trial or open trial, is a type of clinical trial in which both the researchers and participants know which treatment is... Read More
What is the significance of Phase 2b Clinical Trial?
In clinical trial, Phase 1 and 2 trials establish proof-of-concept, and phase 3 trials establish the efficacy and safety of the treatment... Read More
What is Exploratory IND studies?
Posted on31 Dec 2016
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IND stands for Investigational New Drugs. Exploratory IND studies usually involve very limited human exposure and have no therapeutic or diagnostic intent.... Read More
What is the meaning of MASKING (or Blinding)?
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do... Read More
What is the meaning of PIVOTAL TRIAL?
Posted on24 Jul 2016
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A pivotal trial can refer to a clinical trial or study intended to provide evidence for a drug marketing approval, e.g. by... Read More
What is difference between phase IIa and Phase IIb clinical trial?
Posted on24 Jul 2016
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Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements (how... Read More
What is Adaptive clinical trial?
An adaptive clinical trial is a clinical trial that evaluates patients’ reactions to a drug beginning early in a clinical trial and... Read More