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

• Published in: Mutation research. Genetic toxicology and environmental mutagenesis Vol. 868-869; p. 503386
• Main Authors: Robison, Timothy W., Heflich, Robert H., Manjanatha, Mugimane G., Elespuru, Rosalie, Atrakchi, Aisar, Mei, Nan, Ding, Wei
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.08.2021
• Subjects: Comet assay; In vivo mutagenesis; Micronucleus assay; Pig-a mutation assay; Transgenic rodent mutation assay; HESI; In vivo mutagenesis; Micronucleus assay; IWGT; API; TGR mutation assay; Transgenic rodent mutation assay; Pig-a mutation assay; Comet assay

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 recommenda...