DETAILED AND SEQUENTIAL STEPS IN NEW DRUG DEVELOPMENT PROCESS

Drug development is the process of launching a new pharmaceutical drug to the market when the lead compound has been recognized. It includes pre-clinical research on microorganisms and animals, filing for regulatory status, and the step of obtaining regulatory approval. New chemical entities (NCEs) are compounds which come out from the process of drug discovery that are active against a particular disease. The drug development process evaluates the safety, toxicity, pharmacokinetics and metabolism of this NCE prior to human clinical trials. A further major aim of drug development is to set a dose and schedule of NCE in a human clinical trial. Drug development is required to establish the physicochemical properties of the NCE; its chemical makeup, stability as well as solubility. Thus the role of drug development process is vital in the life saving industries.