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Detection of QTc Effects in Small Studies—Implications for Replacing the Thorough QT Study
BACKGROUND: ECG assessment with exposure response analysis applied to data from First‐in‐Man studies has been proposed to replace the thorough QT study for the detection of small QT effects. METHODS: Data from five thorough QT studies, three with moxifloxacin, one study with a drug with a large QTc...
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| Опубликовано в: : | Ann Noninvasive Electrocardiol |
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| Главные авторы: | , , |
| Формат: | Artigo |
| Язык: | Inglês |
| Опубликовано: |
John Wiley and Sons Inc.
2014
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| Предметы: | |
| Online-ссылка: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6931744/ https://ncbi.nlm.nih.gov/pubmed/25367715 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/anec.12227 |
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