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Pilot and Repeat Trials as Development Tools Associated with Demonstration of Bioequivalence

The purpose of this work is to use simulated trials to study how pilot trials can be implemented in relation to bioequivalence testing, and how the use of the information obtained at the pilot stage can influence the overall chance of showing bioequivalence (power) or the chance of approving a truly...

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Detalhes bibliográficos
Publicado no:AAPS J
Autor principal: Fuglsang, Anders
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2015
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4406973/
https://ncbi.nlm.nih.gov/pubmed/25732246
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9744-6
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