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Bioanalysis|December 20, 2024
Comparison of highly sensitive, multiplex immunoassay platforms for streamlined clinical cytokine quantificationKevin McKinski, Huaping Tang, Kai Wang, et al.Journal of Pharmaceutical Analysis|May 18, 2022
Orthogonal quantification of soluble inducible T-cell costimulator (ICOS) in healthy and diseased human serumKevin McKinski, Dean McNulty, Francesca Zappacosta, et al.The AAPS Journal|February 28, 2025
From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-ValidationMianzhi Gu, Andrew Gehman, Brady Nifong, et al.The AAPS Journal|January 24, 2024
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement AssayVeronica Liu, Kelly McGrath, Josh Albert, et al.The AAPS Journal|November 8, 2017
Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic DevelopmentLi Xue, Adrienne Clements-Egan, Lakshmi Amaravadi, et al.The AAPS Journal|January 30, 2016
Pre-existing Antibody: Biotherapeutic Modality-Based ReviewBoris Gorovits, Adrienne Clements-Egan, Mary Birchler, et al.Multiple Sclerosis (Houndmills, Basingstoke, England)|January 17, 2018
Prediction of natalizumab anti-drug antibodies persistencyFlorian Deisenhammer, Marlies Jank, Anna Lauren, et al.EJNMMI Research|May 23, 2019
The biodistribution and clearance of AlbudAb, a novel biopharmaceutical medicine platform, assessed via PET imaging in humansKevin S Thorneloe, Armin Sepp, Sean Zhang, et al.Plos Medicine|October 30, 2020
Clinicogenomic factors of biotherapy immunogenicity in autoimmune disease: A prospective multicohort study of the ABIRISK consortiumSigne Hässler, Delphine Bachelet, Julianne Duhaze, et al.Bioanalysis|May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)Sarah Hersey, Steve Keller, Joel Mathews, et al.Pageof 1