Article
Appropriate in vivo follow-up assays to an in vitro bacterial reverse mutation (Ames) test positive investigational drug candidate (active pharmaceutical ingredient), drug-related metabolite, or drug-related impurity.
Mutation research. Genetic toxicology and environmental mutagenesis - 1 Jan 2000
Robison Timothy W, Heflich Robert H, Manjanatha Mugimane G, Elespuru Rosalie, Atrakchi Aisar, Mei Nan, Ding Wei
Abstract excerpt
Kirkland et al. [Mutation Research/Genetic Toxicology and Environmental Mutagenesis 847 (2019) 403035, https://doi.org/10.1016/j.mrgentox.2019.03.008; Mutation Research/Genetic Toxicology and Environmental Mutagenesis 839 (2019): 21-35, https://doi.org/10.1016/j.mrgentox.2019.01.007] made recommendations on the use of the in vivo comet and transgenic rodent (TGR) gene mutation assays to screen for in vivo...
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