A REVIEW ON GENOTOXICITY, ITS MOLECULAR MECHANISMS, REGULATORY TESTING IN DRUG DEVELOPMENT PROCESSAbstract
Genotoxicity has fully-grown into a serious question for the cause of several cancers. In this article, we discuss the basics of genotoxicity, the chemicals which cause these genetic damages and also their mechanism of action. The discovery of new drug needs a thorough investigation for its safety and efficacy before their release into the market so, the drug development process and drug attrition, regulatory tests to detect compounds with genotoxic and carcinogenic potential are discussed in the article. And also, a brief discussion about the recent advances in genotoxicity testing, pre-clinical investigations generally to obtain the basic fundamental profile of toxicological and new chemical entities (NCE), the integration of the cytogenetic tests into repeated dose toxicity studies can be used to satisfy the in-vivo cytogenetic data requirement in CFR are explained. Finally, a brief account of the drugs being used in present days, and also some plant products which show antimutagenic effects have been emphasized.
P. Radhika and Y. Jyothi *
Department of Pharmacology, Krupanidhi College of Pharmacy, Chikka Bellandur, Bengaluru, Karnataka, India.
12 January 2019
02 April 2019
19 April 2019
01 September 2019