Regulatory scientific advice on non-inferiority drug trials.

The active-controlled trial with a non-inferiority design has gained popularity in recent years. However, non-inferiority trials present some methodological challenges, especially in determining the non-inferiority margin. Regulatory guidelines provide some general statements on how a non-inferiorit...

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Bibliographic Details
Main Authors: Grace Wangge, Michelle Putzeist, Mirjam J Knol, Olaf H Klungel, Christine C Gispen-De Wied, Antonius de Boer, Arno W Hoes, Hubert G Leufkens, Aukje K Mantel-Teeuwisse
Format: article
Language:EN
Published: Public Library of Science (PLoS) 2013
Subjects:
R
Q
Online Access:https://doaj.org/article/41f4581e6bd243c9827bd962f70ffa8c
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