Abstract
There is currently no suitable database pertaining specifically to pharmaceuticals with which to evaluate the impact of carcinogenicity testing on the progression of therapeutic candidates. Concern relating to the current design of lifetime studies has arisen, as it has been shown that studies carried out to regulatory requirements result in the labeling of an increasing number of compounds as suspect or proven “rodent carcinogens.” The results of an international survey of pharmaceutical companies in Europe, Japan, and the United States showed that 67% of the 43 respondents were of the opinion that the rodent lifetime bioassay was only relevant sometimes to the clinical situation. The survey also highlighted 147 pharmaceutical compounds, both terminated (67 compounds) and developed (80 compounds), which had positive results in the lifetime bioassay. These compounds are being followed to establish a database specifically for pharmaceuticals. This database containing information from multiple sources should provide a balanced perspective on the rationale for testing pharmaceuticals using the current design.
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