Article
Genetic toxicity assessment: employing the best science for human safety evaluation. Part I: Early screening for potential human mutagens.
Toxicological sciences : an official journal of the Society of Toxicology - 1 Mar 2007
Jacobson-Kram David, Contrera Joseph F
Abstract excerpt
Results of genetic toxicology tests are used by FDA's Center for Drug Evaluation and Research as a surrogate for carcinogenicity data during the drug development process. Mammalian in vitro assays have a high frequency of positive results which can impede or derail the drug development process. To reduce the risk of such delays, most pharmaceutical companies conduct early non-GLP (good laboratory practices)...
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