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

Drug Regulation - Phase Iii

clinical subjects effects trials disease

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.

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