suratiyasonu@gmail.com

Abstract

The pre-clinical toxicity studies are generally 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. One of the most important aspects of safety pharmacology is the evaluation of genotoxicity potential of the new chemical entities (NCE). Genotoxicity studies are conducted both at nonclinical and clinical levels. Regulatory authorities all over the world require data on the genotoxic potential of NCE as part of the safety evaluation process. Moreover, it is the requirement of OECD guidelines also that a drug molecule should be evaluated for the genotoxicity for its safety. For the evaluation of genotoxicity the bone marrow micronucleus test has been the most suitable test along with some other simultaneously used tests viz., chromosomal aberrations, comet assay and sperm morphology test. This battery of tests would ensure a 100% accurate genotoxicity testing. These assays have been used mainly 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. A 'negative' on these crucial tests takes the sample drug one step closer the market. Keyword: Genotoxicity, Chromosomal Aberration, Comet Assay, Sperm Morphology.