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
Timothy W. Robison, Robert H. Heflich, Mugimane G. Manjanatha, Rosalie K. Elespuru, Aisar Atrakchi, Nan Mei, Wei Ding
Topics & Concepts
In vivoGenotoxicityGene mutationMutationAmes testBiologyPharmacologyMutation frequencyMetaboliteMutagenesisMicronucleus testGeneticsChemistryBiochemistryToxicityGeneBacteriaSalmonellaOrganic chemistryCarcinogens and Genotoxicity AssessmentCRISPR and Genetic EngineeringPharmaceutical and Antibiotic Environmental Impacts