Rosa presents poster “PK Modeling, Simulation, and Scaling of Adult and Pediatric Data to Support International Regulatory Submissions” at 2009 American College of Pharmacometrics (ACoPs) meeting
This poster describes the use of modeling to predict therapy outcomes for European Medicines Agency (EMEA)-approved dose regimens, based on data from the US and US-approved dose regimens. The modeling allowed approval in the EMEA without additional clinical trials.