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Comparing QT interval variability of semiautomated and high‐precision ECG methodologies in seven thorough QT studies—implications for the power of studies intended for definitive evaluation of a drug's QT effect |
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| Authors: | Karin Meiser PhD Pierre Jordaan MD Sasha Latypova MBA Borje Darpo MD PhD |
| Affiliation: | 1. Novartis Pharma AG, Basel, Switzerland;2. iCardiac Technologies, Inc., Rochester, NY, USA;3. Karolinska Institutet, Division of Cardiovascular Medicine, Department of Clinical Sciences, Danderyd's Hospital, Stockholm, Sweden |
| Abstract: | |
| Keywords: | QTc interval ICH E14 TQT studies variability sample size healthy subjects |