Drug Development · Drug - · There are various definitions for drug. · Any substance that brings about a change in biologic function through its chemical action – Katzung. · DRUG DEVELOPMENT PROCESS The process of new drug development are divided to 1) Preclinical 2) clinical PRECLINICAL STUDY · The requirement for preclinical study include adherence to the Good laboratory practice (GLP) for non-clinical studies. These regulations set the minimum basic requirements for: study conduct, Personnel, Facilities, equipment, written protocols, operating procedures, study reports and a system of quality assurance - to ensure the safety of FDA-regulated product. · After preclinical testing à rese...