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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...
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| Publicado no: | Biomed Res Int |
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| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Hindawi Publishing Corporation
2015
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4609768/ https://ncbi.nlm.nih.gov/pubmed/26509147 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1155/2015/293564 |
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