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Abstract Details
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Activity Number:
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580
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Type:
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Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301973 |
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Title:
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Sample Size Determination for Cut Point of Immunogenicity Assays
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Author(s):
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Lanju Zhang and Jianchun Zhang*+ and Harry Yang
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Companies:
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MedImmune, Inc. and MedImmune, Inc.
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Address:
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One Medimmune Way, , ,
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Keywords:
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Confidence interval ;
Nonparametric ;
Quantile
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Abstract:
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Immunogenicity assays are critical for evaluation of safety profiles of biological drugs. Key to the development and validation of an immunogenicity assay validation is the determination of a cut point. Precise estimation of this parameter requires adequate number of test samples. In practice, data for cut point calculation may have a normal, gamma, or any other skewed distributions. This talk centers on sample size determination when the cut point is the defined as a quantile of the underlying distribution.
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Authors who are presenting talks have a * after their name.
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