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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Hindawi Publishing Corporation
2015
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| Materias: | |
| 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 |