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Activity Number:
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307
- Clinical Trial Design-3
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2018 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #328825
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Presentation
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Title:
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Safety Analysis of Clinical Trials in NDA Submissions
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Author(s):
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Linyun Zhou*
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Companies:
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Takeda Global Research & Development
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Keywords:
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clinical trials ;
NDA submissions;
safety analysis
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Abstract:
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This topic will focus on how to analyze safety data for some common safety signal evaluations and safety evidences reviewed in many NDA submissions across different therapeutic areas. The widely used statistical methods in safety analysis for NDA submissions will be introduced. Exploratory safety analysis will be discussed. Multiple past NDA submissions will be presented as example applications of these methods.
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Authors who are presenting talks have a * after their name.
