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Abstract Details
Activity Number:
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627
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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 - #302790 |
Title:
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Interval Estimation for Dichotomized Variables Derived from Continuous Measures in Establishing Acceptance Criteria for Biological Products
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Author(s):
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Jeongsook "Jessica" Kim*+ and Kyunghee Kim Song
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration/CDRH
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Address:
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CBER, Rockville, MD, 20852,
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Keywords:
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dichotomized variable ;
tolerance limit ;
qualitative tests ;
percent of coverage ;
imprecision studies
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Abstract:
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A dichotomized variable derived from a continuous measurement can be used in establishing acceptance criteria for biological products or in making a decision on qualitative diagnostic tests. In this paper, we will investigate tolerance limits with various coverage levels on the original data scale to determine a reasonable threshold value (or a cut-off value) for dichotomizing a given continuous variable. We will examine the corresponding tolerance limits for the dichotomized binomial random variable. We will provide an example of this method using imprecision studies for a qualitative test. An interval that predicts p percent coverage for a dichotomized variable derived from a continuous measure will be compared to the existing standard for qualitative tests.
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