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Article: Phase III clinical development
- Article from:
- Biopharm International
- Article date:
- December 1, 1999
- Author:
CopyrightCopyright Advanstar Communications, Inc. Dec 1999. Provided by ProQuest LLC. (Hide copyright information)
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Time: 2-4 years
Cost: $10-500 million Scale: kilograms of product
Description
During Phase III trials, the company verifies the efficacy of its drug and monitors 1,000-3,000 patient volunteers for adverse events during long-term use. Less than a quarter of INDs make it all the way through Phase III clinical trials.
The number of human subjects involved in a Phase III study depends on the disease being studied. Phase III trials are expensive: Clinical monitoring of patients can include X-rays, blood tests, and other laboratory studies in addition to physician fees and required hospitalizations. Whereas classical pharmaceuticals go through two or more Phase III trials, biopharmaceuticals ...