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.
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| Format: | Online |
| Language: | English |
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BioMed Central
2011
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| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113981/ |
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pubmed-3113981 |
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oai_dc |
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pubmed-31139812011-06-14 Through the looking glass: understanding non-inferiority Schumi, Jennifer Wittes, Janet T 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. |
| repository_type |
Open Access Journal |
| institution_category |
Foreign Institution |
| institution |
US National Center for Biotechnology Information |
| building |
NCBI PubMed |
| collection |
Online Access |
| language |
English |
| format |
Online |
| author |
Schumi, Jennifer Wittes, Janet T |
| spellingShingle |
Schumi, Jennifer Wittes, Janet T Through the looking glass: understanding non-inferiority |
| author_facet |
Schumi, Jennifer Wittes, Janet T |
| author_sort |
Schumi, Jennifer |
| title |
Through the looking glass: understanding non-inferiority |
| title_short |
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_sort |
through the looking glass: understanding non-inferiority |
| 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. |
| publisher |
BioMed Central |
| publishDate |
2011 |
| url |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113981/ |
| _version_ |
1611459595352408064 |