Contribution of modeling and simulation studies in the regulatory review: A european regulatory perspective

Abstract

Modeling and simulation of pharmacokinetic and pharmacodynamic/ response data has been increasingly advocated during drug development, to allow more efficient utilization of collected clinical data and to support informed decision making, e.g., regarding future study designs and dosing strategies in subpopulations. This chapter reflects the view of the Swedish Medical Products Agency, one of the European regulatory bodies, on how M&S studies contribute in the regulatory review. The availability of European guidelines related to modeling and simulation is discussed and some insight is provided into the types of recommendations given, together with a few examples. © American Association of Pharmaceutical Scientists 2011.