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Abstract Details

Activity Number: 134
Type: Contributed
Date/Time: Monday, July 30, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304882
Title: An Alternative Approach to Immunogenicity Assay Cut-Point Determination
Author(s): Jianchun Zhang*+ and Lanju Zhang and Harry Yang
Companies: MedImmune and MedImmune and MedImmune
Address: 868 Quince Orchard Blvd, Gaithersburg, MD, 20878, United States
Keywords: Immunogenicity ; Cut Point ; Non-normality ; anti-drug antibody

Immunogenicity assays are critical for evaluation of safety profiles of biological drugs. Key to the development and validation of an immunogenicity assay is the determination of a cut point, which serves as the threshold for classifying samples as anti-drug antibody (ADA) positive or negative. In practice, the cut point is statistically derived from data based on drug-naïve samples. When its distribution is not normal, the traditional approach based on normal assumption is no longer appropriate. In this talk, we consider an alternative approach to determining the cut point when the distribution is not normal.

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