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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Detalhes bibliográficos
Main Authors: Wangge, Grace, Putzeist, Michelle, Knol, Mirjam J., Klungel, Olaf H., Gispen-De Wied, Christine C., de Boer, Antonius, Hoes, Arno W., Leufkens, Hubert G., Mantel-Teeuwisse, Aukje K.
Formato: Artigo
Idioma:Inglês
Publicado em: Public Library of Science 2013
Assuntos:
Research Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3764030/
https://ncbi.nlm.nih.gov/pubmed/24040346
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1371/journal.pone.0074818
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