Carcinogenicity
Assessing carcinogenic risk in human drug development reviewed
Published in Medical Letter on the CDC and FDA, November 28th, 2004
According to published research from the United States, "Assessing cancer risk for human pharmaceuticals is important because drugs are taken at pharmacologically active doses and often on a chronic basis. Epidemiologic studies on patient populations have limited value because of the long latency period for most cancers and because these studies lack sensitivity. The Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration relies on short-term surrogate assays (genetic toxicology studies) to assess risk to...
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