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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group
2013
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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 |
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). |
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