Meaning of Phase IV Trial
Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
Source: http://evs.nci.nih.gov/ftp1/CDISC/SDTM/SDTM%20Terminology.xls
Web site to visit: http://evs.nci.nih.gov
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