Chapter 1 - Clinical Considerations in the Design, Evaluation, and Development of Novel Therapies

Abstract

Drug discovery has undergone a significant change since its early days. The speedy evolution of scientific discoveries and accompanying social awareness of what constitutes the process of manufacturing and testing of new medicines have made a huge impact on their production and approval for human usage. We are now realizing that the industry pipeline is narrowing more and as a consequence the amount of novel successful product that gets to the market is less than 70% of what it used to be 20 years ago. In this chapter, we analyze some of the reasons behind this realization. The chapter describes the new processes and regulations behind the production and clinical testing of new pharmaceutical products, with a focus in the latest harmonization efforts in the United States and Europe which are becoming worldwide standards.