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Modelling of the outcome of non-inferiority trials by integration of historical data

The approval and differentiation of new compounds in clinical development often demands non-inferiority trials, in which the test drug is compared against a reference treatment. However, non-inferiority trials impose major operational burden with serious ethical and scientific implications for the d...

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Detalles Bibliográficos
Autores principales: Russu, Alberto, van Zwet, Erik, De Nicolao, Giuseppe, Della Pasqua, Oscar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3172410/
https://www.ncbi.nlm.nih.gov/pubmed/21858724
http://dx.doi.org/10.1007/s10928-011-9210-8