Toxicology of Pharmaceutical Products During Drug Development

Abstract

Regulatory toxicology studies are considered the backbone of pharmaceutical research and drug development. The results of the preclinical data are critical to take decisions during the drug development phase. Every new chemical entity or molecule is hazardous in nature. It is the dose that determines its beneficial effects on living creatures like human beings, rodents, etc., and is expressed as a margin of safety. General toxicology includes toxicity studies on rodents and non-rodents, determination of maximum tolerated doses, dose range findings, acute, subacute, and chronic toxicity, no observable adverse effect levels, etc. The core battery of tests on different systems like the cardiovascular system, central nervous system, respiratory system, etc., are also required to be performed during safety pharmacology. Other tests like genotoxicity and carcinogenicity are also being conducted under ICH guidelines during the drug discovery and development phase. Moreover, most importantly, reproductive toxicology studies have also been made mandatory during the drug development phase. Therefore, this chapter explained the role of toxicology studies in pharmaceutical product development, starting from the basics of toxicology to the regulatory requirements of toxicological studies in pharmaceutical product development.