Abstract Details
Activity Number:
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657
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Type:
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Contributed
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Date/Time:
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Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313613
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Title:
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Some Statistical Issues on Immunogenicity Assay Cut Point Determination
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Author(s):
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Jianchun Zhang*+ and Binbing Yu and Harry Yang
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Companies:
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MedImmune and MedImmune and MedImmune
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Keywords:
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Immunogenicity ;
Anti-drug antibodies ;
Cut point ;
Quantile ;
Skew-t Distribution ;
Random Effect Model
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Abstract:
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The development of unwanted immune response to protein therapeutics is a constant concern. Assessment of immunogenicity is critical as the anti-drug antibodies (ADAs) may adversely affect the efficacy and safety of the drug product. Key to the development and validation of an immunogenicity assay is the determination of a cut point, which serves as the threshold for classifying patients as ADA positive or negative. A tiered approach including a screening assay and a confirmatory assay is often adopted. The cut points are statistically derived from data based on drug-naive samples. In this talk, we consider several statistical issues related to cut points.
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Authors who are presenting talks have a * after their name.
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