| Autor: |
Kennedy, Dianne L., Goldman, Stephen A., Lillie, Ralph B. |
| Zdroj: |
Pharmacoepidemiology; 2000 3rd Edition, p149-174, 25p |
| Abstrakt: |
The United States Food and Drug Administration (FDA) has the regulatory responsibility for ensuring the safety of all marketed pharmaceuticals. While the U.S. has one of the most rigorous pre-approval processes in the world, clinical trials cannot uncover every safety problem, and they are not expected to do so. Premarketing clinical trials are effective tools primarily designed for assessing efficacy and risk-benefit ratio. However, due to the limited size and controlled nature of these studies, only the most common adverse events will be observed and subsequently listed in the product's official labeling at the time of approval. The need for postmarketing surveillance is a direct result of these limitations. A degree of uncertainty always exists about both the benefits and risks from pharmaceuticals. |
| Databáze: |
Supplemental Index |
| Externí odkaz: |
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