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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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| Vydáno v: | Ann Noninvasive Electrocardiol |
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| Hlavní autoři: | , , |
| Médium: | Artigo |
| Jazyk: | Inglês |
| Vydáno: |
John Wiley and Sons Inc.
2014
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| Témata: | |
| On-line přístup: | 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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