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Trials. 2011 May 3;12:106. doi: 10.1186/1745-6215-12-106.

Through the looking glass: understanding non-inferiority.

Author information

1
Statistics Collaborative, Inc, Washington DC 20036, USA. jennifer@statcollab.com

Abstract

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.

PMID:
21539749
PMCID:
PMC3113981
DOI:
10.1186/1745-6215-12-106
[Indexed for MEDLINE]
Free PMC Article

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