Modeling and simulation in clinical pharmacology and dose finding.
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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.
SUBMITTER: Staab A
PROVIDER: S-EPMC3600758 | biostudies-other | 2013
REPOSITORIES: biostudies-other
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