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Activity Number:
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614
- Reasonable Possibility - Statistical Science of Safety Monitoring
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 2, 2018 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #330149
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Title:
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The Likelihood Principle and Its Application to Aggregate Safety Monitoring
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Author(s):
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LiAn Lin* and Bill Wang
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Companies:
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and Merck
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Keywords:
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likelihood principle;
safety monitoring;
adverse event
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Abstract:
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Safety monitoring is a continuous process taking place throughout the life cycle of a medical product from pre-clinical to post-marketing. Safety monitoring requires an holistic, accumulative and dynamic approach of integrating medical judgment with quantitative evidence. This presentation will examine the application of likelihood principles in safety monitoring. This includes likelihood approach for blinded and unblinded safety evaluation. We will discuss the level of evidence to establish "Reasonable possibility".
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Authors who are presenting talks have a * after their name.
