Modeling and Simulation in Clinical Pharmacology and Dose Finding. (27th February 2013)

• Record Type: Journal Article
• Authors: Staab, A; Rook, E; Maliepaard, M; Aarons, L; Benson, C
• Is Part Of: CPT: pharmacometrics & systems pharmacology. Volume 2:Number 2(2013)
• Page Start: 1
• Page End: 3
• Publication Date: 2013-02-27
• Subjects: Pharmacokinetics -- Periodicals; Pharmacology -- Periodicals; Pharmacokinetics; Periodicals; 615.05
• DOI: 10.1038/psp.2013.5
• Languages: English
• ISSNs: 2163-8306

Abstract

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