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.
This chapter reflects the view of the Swedish Medical Products Agency and may not be the view of the European Medicines Agency or any other European regulatory agency.
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Dr Monique Wakelkamp is gratefully acknowledged for providing linguistic review.
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Jönsson, S., Henningsson, A., Edholm, M., Salmonson, T. (2011). Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective. In: Kimko, H., Peck, C. (eds) Clinical Trial Simulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 1. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7415-0_2
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