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Activity Number:
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233
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303765 |
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Title:
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Gender Differences in QTcF Based on Moxifloxacin Data
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Author(s):
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Moh-Jee C. Ng*+ and Joanne Zhang and Lihan K. Yan and Qianyu Dang
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Companies:
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FDA and FDA and The George Washington University and FDA
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Address:
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10903 New Hampshire Ave., Silver Spring, MD, 20993,
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Keywords:
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moxifloxacin ; meta analysis ; QTcF ; meta analysis
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Abstract:
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Gender difference in QTcF for moxifloxacin based on 20 submitted thorough QTc studies. We evaluated gender difference of (1) raw QTcF time course based on drug-free data (baseline + placebo); (2) raw QTcF time course based on data after a single dose of moxifloxacin; 3) dQTcF - change from baseline time course for moxifloxacin; (4) ddQTcF - difference between moxifloxacin and placebo after baseline adjustment; (5) meta analysis based on both 14 crossover studies and 6 parallel studies with or without adjusting plasma concentrations and (6) variability of raw QTcF, dQTcF and ddQTcF. Even though we display the whole time course, our focus is to characterize gender difference for moxifloxacin near Tmax.
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