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Drug Regulation

Phase Iii

This phase involves 1,000 to 3,000 subjects with the targeted disease. The disease condition can range from being mild to severe, and the subjects may have other complicating medical conditions. These trials are done in different locations across the country (multicentre). Phase III clinical trials are one to four years in duration, and are done to confirm dosage, monitor unwanted or adverse effects, look for unwanted effects from long-term use, establish the safety profile of the drug, and confirm the efficacy of the drug.

Additional topics

Medicine EncyclopediaAging Healthy - Part 1Drug Regulation - Discovery, Preclinical Testing, Phase I, Phase Ii, Phase Iii, Review By The U.s. Food And Drug Administration - Phase IV, Time and cost