Wednesday 30 November 2011

Anyone know what is designed by phase 3 trial of a drug?

what happens contained by a phase 3 trial?
corrected from other question. Phase 3 Trial is necessarily a larger scale Phase 2 trial. Phase 2 Trials are used within a small percentage of the population to see the efficacy of a drug. It is usually very small clamber, maybe a couple hundred participant. A Phase 3 Trial is for determining the safety AND efficacy of a drug surrounded by a larger population (any unwarranted side effects?). It usually includes several thousand people.
Phase III studies are huge double-blind randomized controlled trials on large forgiving groups (1000-3000 or more) and are aimed at being the definitive assessment of the efficacy of the untried therapy, especially surrounded by comparison with currently available alternatives. Phase III trials are the most expensive, time-consuming and difficult trials to design and run; especially surrounded by therapies for chronic conditions. Once a drug have proven satisfactory over Phase III trials, the trial results are usually combined into a life-size document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life span. This collection of information makes up the "regulatory submission" to be exact provided for review to various regulatory authorities within different countries, such as the Therapeutic Goods Administration (TGA) in Australia, the European Medicines Agency (EMEA) or the Food and Drug Administration (FDA) contained by the United States for marketing approval.
the focus test group is widen to several hundred while animal testing is continued, and origional patients are kept within trial to test for long occupancy exposure risk
fda.gov will have adjectives the details. just do a nonspecific search

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