Article

Statistical Methodology for Qualification of a Non-Clinical Risk Assessment Peptide:T Cell Proliferation Assay to Support Decision Making

2026-06-08

Abstract excerpt

<h4>ABSTRACT</h4> Antibody- and cell-mediated immune responses against biologics, should they occur, can impact treatment efficacy and potentially pose severe risks to patient safety. Therefore, developers have focused on advancing strategies to mitigate such unwanted immunogenicity. Opportunities to address immunogenicity early in the development process, particularly during the drug design phase, have been iden...

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Literature Corpus work: 94205f14-96d7-5b28-9b1d-ea1d6f491b0a
DOI: 10.64898/2026.06.03.729894

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