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Modeling and Simulation in Clinical Pharmacology and Dose Finding

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...

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Detalles Bibliográficos
Autores principales: Staab, A, Rook, E, Maliepaard, M, Aarons, L, Benson, C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3600758/
https://www.ncbi.nlm.nih.gov/pubmed/23835940
http://dx.doi.org/10.1038/psp.2013.5
Descripción
Sumario: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).