Article
An Industry Perspective on the Utility of Short-Term Carcinogenicity Testing in Transgenic Mice in Pharmaceutical Development
5 Nov 2009
Abstract excerpt
International guidelines allow for use of a short-term cancer bioassay (twenty-six weeks) in transgenic mice as a substitute for one of the two required long-term rodent bioassays in the preclinical safety evaluation of pharmaceuticals. The two models that have gained the widest acceptance by sponsors and regulatory authorities are the CB6F1-RasH2 mouse hemizygous for a human H-ras transgene and the...
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