Current industry practices for in-study cut point setting for clinical immunogenicity assays
An immunogenicity assay cut point is defined as the level of response that confirms a sample as anti-drug antibody (ADA) positive or negative. Within the bioanalytical community, there is continued discussion around the best practices for the verification and calculation of in-study cut points. In this commentary, ICON describes observations of current practices for in-study cut point verification and calculation, including when best to use them, how to set them and the consequences of not setting them correctly.
This resource is part of the Bioanalysis Zone Spotlight on immunogenicity assessment of therapeutic proteins. Click here to view the full feature.
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