Modeling and simulation in clinical pharmacology and dose finding

Research output: Contribution to journalArticle

  • Authors:
  • A. Staab
  • E. Rook
  • M. Maliepaard
  • L. Aarons
  • C. Benson

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).© 2013 AScpt.

Bibliographical metadata

Original languageEnglish
Article numbere29
JournalCPT: Pharmacometrics and Systems Pharmacology
Volume2
Issue number2
DOIs
Publication statusPublished - Feb 2013