Through the looking glass: understanding non-inferiority
<p>Abstract</p> <p>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 Fo...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2011-05-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/12/1/106 |
| _version_ | 1818823509203222528 |
|---|---|
| author | Wittes Janet T Schumi Jennifer |
| author_facet | Wittes Janet T Schumi Jennifer |
| author_sort | Wittes Janet T |
| collection | DOAJ |
| description | <p>Abstract</p> <p>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.</p> |
| first_indexed | 2024-12-18T23:41:06Z |
| format | Article |
| id | doaj.art-f64ff5b04ebd4afb81a3704ef912931d |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-18T23:41:06Z |
| publishDate | 2011-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f64ff5b04ebd4afb81a3704ef912931d2022-12-21T20:47:22ZengBMCTrials1745-62152011-05-0112110610.1186/1745-6215-12-106Through the looking glass: understanding non-inferiorityWittes Janet TSchumi Jennifer<p>Abstract</p> <p>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.</p>http://www.trialsjournal.com/content/12/1/106 |
| spellingShingle | Wittes Janet T Schumi Jennifer Through the looking glass: understanding non-inferiority Trials |
| 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 |
| url | http://www.trialsjournal.com/content/12/1/106 |
| work_keys_str_mv | AT wittesjanett throughthelookingglassunderstandingnoninferiority AT schumijennifer throughthelookingglassunderstandingnoninferiority |