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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization

by Sumner, Giane, Keller, Steve, Huleatt, James, Staack, Roland F, Wagner, Leslie, Azadeh, Mitra, Bandukwala, Abbas, Cao, Liching, Du, Xiulian, Salinas, Gabriela Franco, Garofolo, Fabio, Harris, Shannon, Hopper, Shirley, Irwin, Chad, Ji, Qin, Joseph, Julie, King, Lindsay, Kinhikar, Arvind, Lu, Yang, Luo, Rosa, Mabrouk, Omar, Malvaux, Ludovic, Marshall, Jean-Claude, McGuire, Kristina, Mikol, Vincent, Neely, Robert, Qiu, Xiazi, Saito, Yoshiro, Salaun, Bruno, Scully, Ingrid, Smeraglia, John, Solstad, Therese, Stoop, Jeroen, Tang, Huaping, Teixeira, Priscila, Wang, Yixin, Wright, Mike, Mendez, Luis, Beaver, Chris, Eacret, Jacqueline, Au-Yeung, Amelia, Decman, Vilma, Dessy, Francis, Eck, Steven, Goihberg, Polina, Alcaide, Enrique Gomez, Gonneau, Christele, Grugan, Katharine, Hedrick, Michael Nathan, Kar, Sumit, Sehra, Sarita, Stevens, Erin, Stevens, Chad, Sun, Yongliang, McCush, Fred, Williams, LaKenya, Fischer, Sally, Wu, Bonnie, Jordan, Gregor, Burns, Chris, Cludts, Isabelle, Coble, Kelly, Grimaldi, Christine, Henderson, Neil, Joyce, Alison, Lotz, Gregor, Lu, Yanmei, Luo, Linlin, Neff, Florian, Sperinde, Gizette, Stubenrauch, Kay-Gunnar, Wang, Yuting, Ware, Mark, Xu, Weifeng
Published in Bioanalysis (01.08.2023)

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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)

by Kholmanskikh, Olga, Wang, Yow-Ming, Hersey, Sarah, Wadhwa, Meenu, Block, Katherine, Bandukwala, Abbas, Szapacs, Matthew, Weiner, Russell, Awwad, Khader, Dessy, Francis, Downing, Sean, Du, Xiulian, Garofolo, Fabio, Harris, Shannon, Hou, Victor, Jones, Jennifer, Kar, Sumit, Kinhikar, Arvind, Li, Ming, Mathews, Joel, Meissen, John, Sumner, Giane Oliveira, Pan, Luying, Sanderink, Gerard, Scully, Ingrid, Stanta, Johannes, Tanaka, Yoichi, Vauleon, Stephanie, Wagner, Leslie, Wang, Kai, Zhu, Liang, Eck, Steven, Lin, Yi-Dong, Azadeh, Mitra, Decman, Vilma, Diebold, Sandra, Goihberg, Polina, Alcaide, Enrique Gomez, Gonneau, Christele, Hedrick, Michael Nathan, Hopkins, Gregory, Loschko, Jakob, McCausland, Megan, Mendez, Luis, Sehra, Sarita, Stevens, Erin, Sun, Yongliang Steve, Tangri, Shabnam, Trampont, Paul C, Cludts, Isabelle, Dysinger, Mark, Kavita, Uma, Sugimoto, Hiroshi, Chilewski, Shannon, Grimaldi, Christine, Jiang, Yong, Kamerud, John, Liu, Susana, Owen, Carolina, Palackal, Nisha, Petit-Frere, Corinne, Pine, Samuel, Abhari, Mohsen Rajabi, Scheibner, Kara, Williams, LaKenya, Xu, Tao, Zhang, Guodong
Published in Bioanalysis (17.04.2024)

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