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, 12:106

First Online: 03 May 2011Received: 25 August 2010Accepted: 03 May 2011DOI: 10.1186-1745-6215-12-106

Cite this article as: Schumi, J. & Wittes, J.T. Trials 2011 12: 106. doi:10.1186-1745-6215-12-106


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.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-12-106 contains supplementary material, which is available to authorized users.

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Author: Jennifer Schumi - Janet T Wittes


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