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Activity Number: 614 - Reasonable Possibility - Statistical Science of Safety Monitoring
Type: Topic Contributed
Date/Time: Thursday, August 2, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #330149
Title: The Likelihood Principle and Its Application to Aggregate Safety Monitoring
Author(s): LiAn Lin* and Bill Wang
Companies: and Merck
Keywords: likelihood principle; safety monitoring; adverse event

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".

Authors who are presenting talks have a * after their name.

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