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The AAPS Journal|July 11, 2024
Neutralizing Antibody Sample Testing and Report HarmonizationDarshana Jani, Michele Gunsior, Robin Marsden, et al.
The AAPS Journal|December 2, 2021
Anti-drug Antibody Validation Testing and Reporting HarmonizationHeather Myler, João Pedras-Vasconcelos, Kelli Phillips, et al.
The AAPS Journal|July 8, 2023
Neutralizing Antibody Validation Testing and Reporting HarmonizationHeather Myler, João Pedras-Vasconcelos, Todd Lester, et al.
The AAPS Journal|October 28, 2022
Anti-drug Antibody Sample Testing and Reporting HarmonizationDarshana Jani, Robin Marsden, Michele Gunsior, et al.
Bioanalysis|January 25, 2025
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (PART 2A - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)Nicoletta Bivi, Danielle Graham, Laura Joglekar, 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 (PART 2 - 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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