Role of Metabolism in Drug Development

Abstract

Metabolism has gained an exquisite place in the absorption, distribution, metabolism, and elimination (ADME) science, gaining recognition for its utilities in the discovery and development of drugs. This is evident from the guidance issued in recent years by various regulatory bodies. From mere metabolite identification function in the past, the importance of this field today is abundantly evident also in its involvement in enzyme mapping, enzyme polymorphism, and eventually its implications in drug–drug interactions (DDIs), toxicity, efficacy, and pharmacokinetic variability in humans. Case studies have been described to show how the critical studies on metabolism of compounds provide a better understanding of drug efficacy and safety, sometimes lifting a compound from a critically dire stage to a successful launch as a product. Drug metabolism and pharmacokinetic (DMPK) strategy around metabolism group and its readiness to identify and resolve key issues in a prompt manner are covered in this article. Also covered are some new technologies that have emerged recently. The metabolism function will continue to play a key role in the drug discovery and development process.