Cargando…
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.
| Autores principales: | , |
|---|---|
| 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 |
| _version_ | 1782206013921820672 |
|---|---|
| author | Schumi, Jennifer Wittes, Janet T |
| author_facet | Schumi, Jennifer Wittes, Janet T |
| author_sort | Schumi, Jennifer |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-3113981 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2011 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-31139812011-06-14 Through the looking glass: understanding non-inferiority Schumi, Jennifer Wittes, Janet T Trials Review 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. BioMed Central 2011-05-03 /pmc/articles/PMC3113981/ /pubmed/21539749 http://dx.doi.org/10.1186/1745-6215-12-106 Text en Copyright ©2011 Schumi and Wittes; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
| spellingShingle | Review Schumi, Jennifer Wittes, Janet T Through the looking glass: understanding non-inferiority |
| title | Through the looking glass: understanding non-inferiority |
| title_full | Through the looking glass: understanding non-inferiority |
| title_fullStr | Through the looking glass: understanding non-inferiority |
| title_full_unstemmed | Through the looking glass: understanding non-inferiority |
| title_short | Through the looking glass: understanding non-inferiority |
| title_sort | through the looking glass: understanding non-inferiority |
| topic | Review |
| url | 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 |
| work_keys_str_mv | AT schumijennifer throughthelookingglassunderstandingnoninferiority AT wittesjanett throughthelookingglassunderstandingnoninferiority |