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Abstract Details
Activity Number:
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626
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Type:
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Contributed
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Date/Time:
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Thursday, August 4, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #302431 |
Title:
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On Statistical Methods for Out-of-Trend Evaluations
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Author(s):
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Lingmin Zeng*+ and Lanju Zhang and Harry Yang
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Companies:
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MedImmune, Inc. and MedImmune, Inc. and MedImmune, Inc.
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Address:
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One MedImmune Way, Gaithersburg, MD, 20878,
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Keywords:
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out of trend ;
stability ;
monitor
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Abstract:
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Stability data are often collected to monitor and ensure quality of a pharmaceutical product. One of the important aspects of stability analysis is to identify out-out-trend (OOT) results. It has rapidly gained regulatory interest in the past decade. Although in the literature, several statistical methods have been developed, little has been done to compare the methods. In this talk, we discuss the pros and cons of the currently available OOT methods used in various phases of product development.
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