Genetic Toxicology studies are designed to test whether your compound has mutagenic or carcinogenic potential. Generally, a bacterial gene mutation assay (Ames test) and an in vitro mammalian cell assay for chromosome damage are performed prior to phase 1 clinical trials. vivoPharm conducts its genetic toxicology studies in a tiered approach, starting with an Ames test and progressing to the conduct of in vitro and in vivo assays, which are designed to assess the toxicological relevance of any earlier observations.
vivoPharm's genetic toxicology studies can include:
Cytotoxicity
Bacterial mutation (Ames)
Chromosome aberration (in partnership with TetraQ)
Mammalian cell mutation (mouse lymphoma L5178Y TK assay)
UDS (in vivo rodent liver and in vitro hepatocyte) (in partnership with TetraQ)