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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,Meenu Wadhwa, Katherine Block,Abbas Bandukwala,Matthew Szapacs,Russell Weiner, Khader Awwad,Francis Dessy,Sean Downing,Xiulian Du,Fabio Garofolo,Shannon Harris, Victor Hou,Jennifer Jones,Sumit Kar,Arvind Kinhikar, Ming Li,Joel Mathews, John Meissen,Giane Oliveira Sumner,Luying Pan, Gerard Sanderink,Ingrid Scully, Johannes Stanta,Yoichi Tanaka,Stephanie Vauleon,Leslie Wagner, Kai Wang, Liang Zhu,Steven Eck,Yi-Dong Lin,Mitra Azadeh,Vilma Decman, Sandra Diebold,Polina Goihberg,Enrique Gomez Alcaide,Christele Gonneau,Michael Nathan Hedrick,Gregory Hopkins,Jakob Loschko,Megan Mccausland, Luis Mendez,Sarita Sehra,Erin Stevens,Yongliang Steve Sun,Shabnam Tangri,Paul C. Trampont,Isabelle Cludts,Mark Dysinger,Uma Kavita,Hiroshi Sugimoto,Shannon Chilewski,Christine Grimaldi,Yong Jiang,John Kamerud,Susana Liu, Carolina Owen,Nisha Palackal,Corinne Petit-frere,Samuel Pine,Mohsen Rajabi Abhari,Kara Scheibner,Lakenya Williams, Tao Xu, Guodong Zhang

BIOANALYSIS（2024）

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Key words
bioanalysis,biomarkers,cell therapy,gene therapy,immunogenicity,vaccine,WRIB
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