ABSTRACT
A number of published reports have addressed the fundamental problems that affect the pharmaceutical and biotechnology industries today (1, 2). The cost of drug development continues to increase, the time from drug discovery to peak sales is thought to be too long, and the amount of data and information arising from clinical trials is increasing exponentially, thereby complicating its interpretation. The solution to these problems is not always clear or simple. Increasingly, the pharmaceutical industry is looking toward new paradigms of drug development to deal with these issues, and in almost all cases, new technology is viewed as one way to overcome the challenges and the obstacles to achieving a more affordable, efficient, and informative drug development process. Among the technology-enabling solutions for which there are high expectations in the next 5-10 years include such platforms as pharmacogenomics, biomarkers, bioinformatics, and modeling and simulation (M&S). This chapter will focus only on the regulatory perspectives of M&S, or more specifically clinical trial simulation (CTS).
