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Activity Number:
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29
- Bayesian Methods and Applications in Clinical Trials (I)
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Type:
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Contributed
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Date/Time:
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Sunday, July 30, 2017 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #322630
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Title:
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Statistical Innovations on Safety Analyzes
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Author(s):
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Shuai Yuan* and William W Wang
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Companies:
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Merck and Merck & Co Inc
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Keywords:
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Safety Monitoring ;
FDA IND Safety Reporting Guidance ;
Bayesian ;
Visual Analytics ;
Dynamic Volcano Plot
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Abstract:
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Safety is a critical part in drug development. Both regulatory and industry have put more and more emphasis on the safety mornitoring and analysis during the course of drug development and new drug filing. In this talk, we are going to introduce some innovative Bayesian applications on safety monitoring which is designed to satisfy the FDA IND safety reporting guidance. Visual analytical tools are an important bridge between statisticians and physicians. A dynamic volcano plot based on the proposed Bayesian methods is also introduced in this presentation.
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Authors who are presenting talks have a * after their name.
