The investigator will evaluate 4 compounds in (a) the bacterial mutagenesis assay, (b) the mouse lymphoma assay, and (c) the mouse micronucleus assay. Rangefinding studies will be conducted to select doses for the formal studies. The homogeneity, concentration, and stability of the test articles under the conditions of use will be assessed. The studies will be conducted under GLP guidelines and the International Committee on Harmonization Guidelines on Regulatory Genotoxicity Tests for submissions to the FDA.
| Doppalapudi, Rupa S; Riccio, Edward S; Rausch, Linda L et al. (2007) Evaluation of chemopreventive agents for genotoxic activity. Mutat Res 629:148-60 |
