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...

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Detalles Bibliográficos
Autores principales: Harnisch, L, Shepard, T, Pons, G, Della Pasqua, O
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2013
Materias:
Perspective
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

Internet

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

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