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Abstract Details
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Activity Number:
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457
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301559 |
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Title:
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Early Detection Claim in IVD Devices: Statistical Issues and Challenges
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Author(s):
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Chunrong Cheng*+ and Tie-Hua Ng
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration
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Address:
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R471S 1401 Rockville Pike, Rockville, MD, 20852, USA
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Keywords:
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IVD ;
early detection ;
window period
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Abstract:
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The "window period" is the time of infection of a virus (e.g., HIV) to the time that the infection could be detected by an in vitro diagnostics (IVD) devices. Shortening the window period could mean early detection. Claim for an early detection can be made by improving the IVD devices and technologies amplifying antigen/antibody production. However, assessing early detection faces major challenges such as study design, sample selection, sample size, etc. We will discuss the related statistical issues from a regulatory perspective. We hope to stimulate a discussion that may lead to solutions to these challenges.
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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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