ABSTRACT
Applications ...................................................................................... 180 5.9 Future Directions and Summary .................................................................. 184 References .............................................................................................................. 184
Discovering and developing safe, ef cacious, and commercially successful drugs is a long, complex, risky, and costly process. The process has yielded many medicines that have had dramatic positive in uences on public health. A typical drug discovery and development process leading up to registration involves a discovery phase, a preclinical development phase, and clinical Phases I, II, and III. According to current estimates, advancing a small molecule drug through all the phases can take between 10 and 15 years and cost over $800 million. Although the pharmaceutical industry’s investment in research and development has been constantly increasing, the number of new molecular entities (NMEs) reaching the market has been steadily decreasing.
