Modeling and simulation in clinical pharmacology and dose finding.

ABSTRACT

The breakout session 2 of the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations Modeling and Simulation (M&S) workshop focused on two topics when and how M&S should be used and would be accepted by the authorities for the dose-regimen selection; and when and how M&S can be applied to register a dosing regimen without the need for a specific study. Each topic was introduced by an industry and regulatory perspective, followed by case examples for illustration (Table 1).CPT Pharmacometrics & Systems Pharmacology (2013) 2, e29; doi10.1038/psp.2013.5; advance online publication 27 February 2013.