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Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design

In order to help companies qualify and validate the software used to evaluate bioequivalence trials with two parallel treatment groups, this work aims to define datasets with known results. This paper puts a total 11 datasets into the public domain along with proposed consensus obtained via evaluati...

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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Fuglsang, Anders, Schütz, Helmut, Labes, Detlew
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4365103/
https://ncbi.nlm.nih.gov/pubmed/25488055
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9704-6
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