ABSTRACT
Drug development is a complex, risky, and expensive endeavor. The process of generating evidence that a new chemical entity is safe and effective in treating a disease in a highly regulated environment can involve hundreds of people across dozens of scientific specialties. Each stage of development requires a unique set of expertise to successfully move to the next stage. This chapter describes the major activities involved in preclinical development, early clinical development, late clinical development, registration, and lifecycle management. The traditional approach is described as well as innovative development strategies that aim to shorten development times and reduce development costs.
