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Bioanalysis|June 25, 2026
Advancing beyond stand-alone NAb assays: perspectives and regulatory impact of applying integrated immunogenicity assessment in drug developmentKirstee Martin, Marit Lichtfuss, Devangi MehtaJournal of Immunological Methods|April 2, 2013
Novel data analysis methods to overcome cut point challenges and enable comprehensive assessment of antidrug binding activity in confirmatory assaysAlvydas Mikulskis, Dave Yeung, Weiping Chen, et al.Bioanalysis|May 5, 2026
Rethinking immunogenicity: an integrated approach reveals the PK/PD impact of pre-existing and drug-sustaining ADADevangi Mehta, William Wargin, Stephanie Wallace-Teliz, et al.British Journal of Clinical Pharmacology|June 23, 2016
Population PK-PD analyses of CD25 occupancy, CD56bright NK cell expansion, and regulatory T cell reduction by daclizumab HYP in subjects with multiple sclerosisLei Diao, Yaming Hang, Ahmed A Othman, et al.Neurology(R) Neuroimmunology & Neuroinflammation|November 22, 2017
Immune response to vaccines is maintained in patients treated with dimethyl fumarateChristian von Hehn, Jonathan Howard, Shifang Liu, et al.Neurology|March 29, 2019
Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practiceDevangi Mehta, Catherine Miller, Douglas L Arnold, et al.Journal of Medicinal Chemistry|July 23, 2020
Discovery of BIIB068: A Selective, Potent, Reversible Bruton's Tyrosine Kinase Inhibitor as an Orally Efficacious Agent for Autoimmune DiseasesBin Ma, Tonika Bohnert, Kevin L Otipoby, et al.Clinical & Translational Immunology|June 18, 2021
Next-generation Bruton's tyrosine kinase inhibitor BIIB091 selectively and potently inhibits B cell and Fc receptor signaling and downstream functions in B cells and myeloid cellsEris Bame, Hao Tang, Jeremy C Burns, et al.Bioanalysis|December 6, 2017
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays)Shalini Gupta, Susan Richards, Lakshmi Amaravadi, et al.Bioanalysis|December 11, 2019
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)Steven Piccoli, Devangi Mehta, Alessandra Vitaliti, et al.Pageof 2