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Design considerations and analysis planning of a phase 2a proof of concept study in rheumatoid arthritis in the presence of possible non-monotonicity

BACKGROUND: It is important to quantify the dose response for a drug in phase 2a clinical trials so the optimal doses can then be selected for subsequent late phase trials. In a phase 2a clinical trial of new lead drug being developed for the treatment of rheumatoid arthritis (RA), a U-shaped dose r...

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Detalhes bibliográficos
Publicado no:BMC Med Res Methodol
Main Authors: Liu, Feng, Walters, Stephen J., Julious, Steven A.
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2017
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5625783/
https://ncbi.nlm.nih.gov/pubmed/28969588
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s12874-017-0416-3
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