The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study

Concentration-effect (CE) models applied to early clinical QT data from healthy subjects are described in the latest E14 Q&A document as promising analysis to characterise QTc prolongation. The challenges faced if one attempts to replace a TQT study by thorough ECG assessments in Phase I based o...

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Detalles Bibliográficos
Autores principales: Ferber, Georg, Lorch, Ulrike, Täubel, Jörg
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2015
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609768/
https://www.ncbi.nlm.nih.gov/pubmed/26509147
http://dx.doi.org/10.1155/2015/293564

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609768/
https://www.ncbi.nlm.nih.gov/pubmed/26509147
http://dx.doi.org/10.1155/2015/293564

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