Genetic Toxicology
ITR Laboratories can assess the potential of your therapeutic to cause genetic damage using a standard test battery for genotoxicity as specified in ICH S2 (R1) and OECD test guidelines.
ITR Laboratories genetic toxicology services are performed to GLP standards in our modern facility in Montreal, Canada.
- Chromosomal aberration
- Mouse lymphoma
- Micronucleus
- Comet
- Neutral red uptake
- Bacterial reverse mutation assays
- Screening assay non-GLP (between 2 and 5 strains)
- Standard assay (5 strains)
- Enhanced (5 strains, improved detection of N-nitrosamines and related impurities)
- Chromosomal damage assay using:
- Micronucleus in bone marrow erythrocytes
- Micronucleus in peripheral blood erythrocytes
- Chromosomal damage in bone marrow cells
- Comet
- Gene mutation assay using:
- Pig-A
In addition to the standard battery of tests, ITR will validate additional assays to keep pace with the creativity and needs of its clients.