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Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal

John Garlits,Sean McAfee,Jessica-Ann Taylor, Enoch Shum,Qi Yang, Emily Nunez, Kristina Kameron,Keilah Fenech, Jacqueline Rodriguez,Albert Torri,Jihua Chen,Giane Sumner,Michael A. Partridge

The AAPS Journal(2023)

引用 4|浏览10
关键词
anti-drug antibody (ADA) assay,cut point determination,immunogenicity,outlier removal,therapeutic protein products
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