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Through the looking glass: understanding non-inferiority

Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.

Detalles Bibliográficos
Autores principales: Schumi, Jennifer, Wittes, Janet T
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113981/
https://www.ncbi.nlm.nih.gov/pubmed/21539749
http://dx.doi.org/10.1186/1745-6215-12-106