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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Detalles Bibliográficos
Autores principales: Liu, Feng, Walters, Stephen J., Julious, Steven A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5625783/
https://www.ncbi.nlm.nih.gov/pubmed/28969588
http://dx.doi.org/10.1186/s12874-017-0416-3

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5625783/
https://www.ncbi.nlm.nih.gov/pubmed/28969588
http://dx.doi.org/10.1186/s12874-017-0416-3

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