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Activity Number: 657
Type: Contributed
Date/Time: Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #313613
Title: Some Statistical Issues on Immunogenicity Assay Cut Point Determination
Author(s): Jianchun Zhang*+ and Binbing Yu and Harry Yang
Companies: MedImmune and MedImmune and MedImmune
Keywords: Immunogenicity ; Anti-drug antibodies ; Cut point ; Quantile ; Skew-t Distribution ; Random Effect Model
Abstract:

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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