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Glossary Terms

Phase III clinical trial (phase 3 clinical trial)

Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labelling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. (CDISC v 9.0)

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