Genotoxicity describes the property of chemical compounds that damages the genetic information within a cell causing mutations, which may lead to cancer. Genotoxic chemicals exert their adverse effect through interaction with genetic material (DNA) of cells. Genotoxicity testing of new chemical entities is an integral part of the drug development process and is a regulatory necessity prior to the approval of new drugs. To assay for genotoxic molecules, researchers assay for DNA damage in cells exposed to the toxic substrates. Techniques like in vitro and in vivo Toxicology Tests, Ames Assay and Comet Assay have been developed to determine the chemicals' potential to cause DNA damage that may lead to cancer. Genotoxicity tests are designed to detect drugs which can cause genetic damage directly or indirectly by various mechanisms of action. Compounds which are identified as genotoxic in these tests have the ability to be human carcinogens and ultimately may induce cancer and heritable defects. Genotoxicity testing of new chemical entities is an integral part and is a regulatory requirement prior to the approval of new drugs, in Drug Development process. Late stage failures can be reduced by identifying genotoxicity at an early stage in Drug Discovery rather than during regulatory assessment.

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