Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity

The most recent International Conference on Harmonisation E14 Q&A document states that a separate positive control would not be necessary provided sufficiently high exposures are achieved in the early‐phase studies. Realistically, a phase 1 study is unlikely to include a pharmacological positive...

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Detalles Bibliográficos
Autores principales: Ferber, Georg, Fernandes, Sara, Täubel, Jörg
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Drug Development
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5763401/
https://www.ncbi.nlm.nih.gov/pubmed/28833240
http://dx.doi.org/10.1002/jcph.975

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5763401/
https://www.ncbi.nlm.nih.gov/pubmed/28833240
http://dx.doi.org/10.1002/jcph.975

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