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There have been tremendous advancements in application of modeling and simulation (M&S) in drug development during the last decade. The pharmaceutical companies started to pay more attention to implement simulation exercises in drug development in order to achieve cost effectiveness. The Food and Drug Administration (FDA) published a white paper titled, Critical Path Initiatives, in March 2004. This puts forward model based drug development that calls for use of quantitative M&S to facilitate informed decisions. The European Medicines Agency (EMEA) also encourages use of simulations in...

There have been tremendous advancements in application of modeling and simulation (M&S) in drug development during the last decade. The pharmaceutical companies started to pay more attention to implement simulation exercises in drug development in order to achieve cost effectiveness. The Food and Drug Administration (FDA) published a white paper titled, Critical Path Initiatives, in March 2004. This puts forward model based drug development that calls for use of quantitative M&S to facilitate informed decisions. The European Medicines Agency (EMEA) also encourages use of simulations in...