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Abstract Details
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Activity Number:
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648
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304452 |
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Title:
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Study Design Issues and Statistical Challenges in Personalized Medicine Bridging Studies
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Author(s):
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Meijuan Li*+
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Companies:
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FDA/CDRH
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Address:
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6505 Evening Shadows Ct., Clarksville, MD, 21029-1543, United States
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Keywords:
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personalized medicine ;
bridging studies ;
Market ready test ;
laboratory developed test ;
marker positive ;
efficacy
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Abstract:
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The most prominent examples of modern personalized medicine are genetic/genomic tests designed to guide treatment choices. Some are widely recognized as useful, such as testing for human epidermal growth factor receptor type 2 (HER2, also referred to as HER2/neu) to select patients with breast cancer who will benefit from trastuzumab. A new trend in personalized medicine is to bridge from a laboratory developed test (LDT) to a Market ready test (MRT) for detecting patient marker status, even though a MRT wasn't considered in the original Phase III clinical trial of the drug. In this talk, we will discuss design issues and challenges in bridging studies.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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