By Craig Morgan, goBalto
Improving experimental drug success rate1 and accelerating clinical development2 are top priorities for pharmaceutical companies. Careful decision making during drug development is essential to minimize development time, manage costs and improve the probability of commercial success. Recently, many of the major pharmaceutical companies have begun to explore computer-based bio-simulation strategies to help generate the information necessary to make better decisions.3,4 These strategies go by many different names – clinical trial simulation (CTS), modeling and simulation (M&S), computer-assisted trial design (CATD), model-based drug development (MBDD), and model-informed drug discovery and development (MID3). The FDA and EMA regulatory agencies have also taken notice of M&S strategies in an effort to support improved drug development efficiencies.