ABSTRACT
This chapter outlines contemporary practices in new drug discovery and development, with an emphasis on the interdisciplinary process, stage-gate paradigm, and the key features that ensure safety and efficacy of every new drug through the earliest stages of drug discovery by commercialization. Discovery of new drug candidates relies on target screening and validation efforts to not only identify the right target but also provide a high-throughput screening assay to shortlist compounds from vast institutional libraries and synthetic capabilities. In addition to the use of whole animals, cultures of cells and tissues from animal and human origin are routinely used for the discovery and development of new drugs—both small molecules and biologicals, such as vaccines. Government regulatory agencies that monitor and control the commercialization and utilization of drug products vary by each country and as do their requirements for the testing and commercialization of new drug products.
