A Comprehensive Study for The Regulations of Genotoxic Impurities in Pharmaceutical Drug Substances & Products with Special Reference to Their Detection, Identification and Evaluatione

Abstract

Since the turn of the millennium, the issue of Genotoxic Impurities (GTIs) has perhaps been one of the most emotive issues facing the Pharmaceutical Industry. Regulations for GTIs is always a great challenge to Drug regulators in the world. The Dissertation includes Introduction of GTIs & Regulatory current scenario of the GTIs. This Dissertation also includes the types of GTIs, their Classification, History alongwith some case studies. Then also performed In silico / In vivo-In vitro methods for identification of different structural alerts/drugs with plausible predicition of some drugs from different categories by using Derek Nexus & Toxtree softwares based on In silico methods. The GTIs in recent years are one of the most famous topic of concern between all the regulators in the world & its evaluation is also one of the primary concern.