未登录2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A-Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B-Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))2025年生物分析近期问题白皮书：生物标志物校准与稳定性；NULISA评估；神经丝蛋白与自身抗体生物标志物检测；去除IgM干扰；ELISpot与FluoroSpot最佳实践；模块化高维度细胞计数；单细胞分析成像细胞计数（第二部分A-关于生物标志物发现、开发、验证与监管批准、配体结合检测（LBA）和细胞基础检测（CBA）的建议；第二部分B-监管机构对生物标志物、体外诊断（IVD）/伴随诊断（CDx）和生物标志物检测验证（BAV）的反馈）
Hersey, Sarah; McGuire, Kristina; Kholmanskikh, Olga; Bivi, Nicoletta; Bandukwala, Abbas; Gong, Binsheng; Irwin, Chad; Ray, Soma; Gunsior, Michele; Avanesov, Andrei; Baker, Brian; Bond, Sarah; Braun, Alexander; Buoninfante, Alessandra; Dessy, Francis; Fang, Xiaodong; Garofolo, Fabio; Gomme, Emily; Hays, Amanda; King, Lindsay; Mayer, Christian; McGregor, Jessica; McHenry, Melis; Nowocin, Anna; Rubel, Carrie; Sanderink, Gerard; Scott, Bradley; Scully, Ingrid; Seyda, Agnes; Stoop, Jeroen; Tang, Huaping; Tavares Neto, Joao; Walravens, Karl; Wang, Kai; Wassmer, Sarah; Xiao, Wenming; Zhu, Liang; Zoghbi, Jad; Brockus, Catherine; Petit-Frere, Corinne; Coble, Kelly; Fischer, Sally; Yearwood, Graham; Cao, Liching; Dysinger, Mark; Grimaldi, Christine; Jiang, Yong; Joyce, Alison; Kerridge, Claire; Lu, Kun; McCush, Fred; Nolan, Katrina; O'Connor, Ellen; Palmer, Rachel; Reese, Kimberly; Stubenrauch, Kay-Gunnar; Verch, Thorsten; Beaver, Christopher; Mendez, Luis; Decman, Vilma; Bhavaraju, Kamala; Huleatt, James; Trampont, Paul C.; Eck, Steven; Goihberg, Polina; Alcaide, Enrique Gomez; Hedrick, Michael Nathan; Jalah, Rashmi; McGrath, Shannon; Ogorman, William; Prior, Sandra; Sehra, Sarita; Shaik, Saleem; Standifer, Nathan; Stevens, Chad; Stevens, Erin; Sun, Yongliang (Steve) .png)
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收藏Neutralizing Antibody Validation Testing and Reporting HarmonizationMyler, Heather; Pedras-Vasconcelos, Joao; Lester, Todd; Civoli, Francesca; Xu, Weifeng; Wu, Bonnie; Vainshtein, Inna; Luo, Linlin; Hassanein, Mohamed; Liu, Susana; Ramaswamy, Swarna Suba; Mora, Johanna; Pennucci, Jason; McCush, Fred; Lavelle, Amy; Jani, Darshana; Ambakhutwala, Angela; Baltrukonis, Daniel; Barker, Breann; Carmean, Rebecca; Chung, Shan; Dai, Sheng; DeWall, Stephen; Dholakiya, Sanjay L.; Dodge, Robert; Finco, Deborah; Yan, Haoheng; Hays, Amanda; Hu, Zheng; Inzano, Cynthia; Kamen, Lynn; Lai, Ching-Ha; Meyer, Erik; Nelson, Robert; Paudel, Amrit; Phillips, Kelli; Poupart, Marie-Eve; Qu, Qiang; Abhari, Mohsen Rajabi; Ryding, Janka; Sheldon, Curtis; Spriggs, Franklin; Warrino, Dominic; Wu, Yuling; Yang, Lin; Pasas-Farmer, Stephanie 分享 收藏 
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