As a part of the safety evaluation process, regulatory authorities worldwide require data on the genotoxic potential of new drugs. The pre-clinical studies are conducted to obtain the basic toxicological profile of new chemical entities (NCE). The toxicological data are used to evaluate the safety and efficacy of NCE, which will help in predicting the drug's likely risk/benefit assessment during New Drug Application (NDA) process. Genotoxicity assays have become an integral component of regulatory requirement. It has become mandatory to include genotoxicity assay in drug master file required by United States and European regulatory authorities.
Genotoxicity testing of NCE is usually used for hazard identification with respect to DNA damage and its fixation. These damages can be manifested in the form of gene mutation, structural chromosomal aberration, recombination and numerical changes. These changes are responsible for heritable effects documented that somatic mutations can play a significant role in malignancy. These tests have been mainly used for the prediction of carcinogenicity and genotoxicity because compounds, which are positive in these tests, have the potential to be human carcinogens and/or mutagens.
Figure 1. The damages of chromosome and DNA
Our Genotoxicity Testing
Creative Animodel offers a range of screening services to identify genotoxicity. By identifying genotoxicity at an early stage in drug discovery rather than during regulatory assessment, the likelihood of late-stage failures is reduced. Our various genotoxicity testing services include:Ames testMicronucleus testMouse lymphoma assayChromosome aberration testComet assay
Creative Animodel has professional teams with rich experience in toxicology studies. We offer high-quality data and rapid turnaround period to support your drug discovery and development. The toxicological evaluation from dose design, in-life studies to histology and pathology assays along with toxicokinetic studies are all compliant with GLP or non-GLP standards.