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Futility Rules in Bioequivalence Trials with Sequential Designs

Health Canada, the US Food and Drug Administration, as well as the European Medicines Agency consider sequential designs acceptable for bioequivalence studies as long as the type I error is controlled at 5%. The EU guideline explicitly asks for specification of stopping rules, so the goal of this wo...

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Autor principal: Fuglsang, Anders
Format: Artigo
Idioma:Inglês
Publicat: Springer US 2013
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC3889523/
https://ncbi.nlm.nih.gov/pubmed/24218038
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9540-0
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