Genotoxic impurities of pharmaceutical products or genotoxic chemicals exert their adverse effects through interaction with genomic DNA of cells. Genetic toxicology tests are designed to detect drugs which can induce genetic damage directly or indirectly by various mechanisms. Compounds that are identified as genotoxic in these tests have the potential to be human carcinogens and/or mutagens, and ultimately may induce cancer and/or heritable defects.
Testing for genotoxic impurities and new chemical entities is an integral part of the drug development process and is a regulatory requirement prior to the approval of new drugs. By identifying genotoxicity at an early stage in drug discovery rather during regulatory assessment, the likelihood of late stage failures is reduced.
Sugen offers a range of screening (GLP-compliance) services to identify genotoxicity and our dedicated team of scientists has vast experience in all aspects of genetic toxicology to evaluate a variety pharmaceutical products.
In vitro Bacterial Reverse Mutation Test (Ames Test).
Chromosomal abnormalities :
In vivo Mammalian Erythrocyte Micronucleus Test in Mice.
In vivo Mammalian Bone Marrow Chromosome Aberration Test in Mice.