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Bioanalysis|November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)Hendrik Neubert, Timothy Olah, Anita Lee, et al.
Bioanalysis|November 18, 2017
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers)Jan Welink, Eric Yang, Nicola Hughes, et al.
Bioanalysis|December 6, 2017
2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs)Hendrik Neubert, An Song, Anita Lee, et al.
Bioanalysis|December 23, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input)Dawn Dufield, Hendrik Neubert, Fabio Garofolo, et al.
Bioanalysis|June 20, 2024
2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (<u>PART 2</u> - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)Olga Kholmanskikh, Yow-Ming Wang, Sarah Hersey, et al.
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