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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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Bibliografiske detaljer
Udgivet i:AAPS J
Hovedforfatter: Fuglsang, Anders
Format: Artigo
Sprog:Inglês
Udgivet: Springer US 2015
Fag:
Online adgang: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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