title: 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; doi:10.1038/psp.2013.5; advance online publication 27 February 2013.
authors.affiliation: Translational Medicine, Pharmacometrics, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Staab
authors.forename: E
authors.initials: E
authors.lastname: Rook
authors.forename: M
authors.initials: M
authors.lastname: Maliepaard
authors.forename: L
authors.initials: L
authors.lastname: Aarons
authors.forename: C
authors.initials: C
authors.lastname: Benson