4.1 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

Related references

Note: Only part of the references are listed.
Article Chemistry, Medicinal

Genotoxicity Assessment of Drug Metabolites in the Context of MIST and Beyond

Andreas Zeller et al.

CHEMICAL RESEARCH IN TOXICOLOGY (2020)

Article Biotechnology & Applied Microbiology

A comparison of transgenic rodent mutation and in vivo comet assay responses for 91 chemicals

David Kirkland et al.

MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS (2019)

Review Genetics & Heredity

The micronucleus test-most widely used in vivo genotoxicity test-

Makoto Hayashi

GENES AND ENVIRONMENT (2016)

Article Biotechnology & Applied Microbiology

Critical issues with the in vivo comet assay: A report of the comet assay working group in the 6th International Workshop on Genotoxicity Testing (IWGT)

Guenter Speit et al.

MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS (2015)