1 Modeling and Simulation as Tools to Improve Drug Development

Healthcare remains a national crisis. Among the associated issues are the high cost of medications and the expenses of those patients whose disease can not be managed effectively with the currently available drugs. There is a strong focus on reducing the costs of medication and reducing the time required to develop and test medications for unmet medical needs. Computer based modeling and simulation can be used to reduce drug development costs and help evaluate new therapies. Population modeling techniques are used to evaluate the time course of disease in untreated and treated conditions and to provide additional insights into the therapeutic benefit a new drug may provide. These models are then used to simulate alternative dose and treatment strategies to reduce the number of regimens tested in clinical trials. This approach provides more rapid drug development at reduced cost. Some pharmaceutical companies and regulatory agencies are strong proponents of population modeling and simulation. There are many cases where such models have been used to improve the safety and efficacy of new drugs, and to reduce development times. However the application of modeling and simulation to drug development is still a relatively new approach and its implementation is not consistently applied across all drug development programs