JSM 2011 Online Program

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Abstract Details

Activity Number: 627
Type: Contributed
Date/Time: Thursday, August 4, 2011 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302790
Title: Interval Estimation for Dichotomized Variables Derived from Continuous Measures in Establishing Acceptance Criteria for Biological Products
Author(s): Jeongsook "Jessica" Kim*+ and Kyunghee Kim Song
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration/CDRH
Address: CBER, Rockville, MD, 20852,
Keywords: dichotomized variable ; tolerance limit ; qualitative tests ; percent of coverage ; imprecision studies
Abstract:

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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