Genotoxicity, risk-benefit

The demonstration of genotoxic activity in a pharmaceutical molecule may not necessarily translate into discontinuation of development and ultimate licensing of the product to be marketed. A survey of the Physicians Desk Reference reveals many examples of pharmaceutical products that have been shown to elicit genotoxic activity in one or more gene-tox assays.41 This observation indicates that other factors (such as risk, benefit, seriousness of ailment, target patient population, dosage, and frequency of administration, among others) are taken into consideration. 

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