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Modeling and Simulation as a Tool to Bridge Efficacy and Safety Data in Special Populations
The registration and approval of novel medicines have traditionally been based on evidence arising from large prospective trials. Such an approach is often not possible or unsuitable to evaluate the benefit-risk balance in special populations (e.g., children, ethnic groups, rare diseases). Inference...
| 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/PMC3600759/ https://www.ncbi.nlm.nih.gov/pubmed/23835939 http://dx.doi.org/10.1038/psp.2013.6 |