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Lancet (London, England)|May 25, 2025
Antisense oligonucleotide jacifusen for FUS-ALS: an investigator-initiated, multicentre, open-label case seriesNeil A Shneider, Matthew B Harms, Vlad A Korobeynikov, 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.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 (<u>Part 2</u> - 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.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