ABSTRACT
In the pharmaceutical industry, identification of a development drug candidate (preclinical lead profile, PLP, or early candidate notification, ECN), fi ling of investigational new drug application (IND), and new drug application (NDA) are important milestones before the launch of a new drug. This entry works to outline this process, and in doing so discusses the chemist’s viewpoint of drug development, the general process of research and development, and the role of outsourcing in the pharmaceutical industry.
