Nicoletta Bivi

us food & drug administration (fda)

H指数:21

被引数:2,405

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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）

Bioanalysis

IF1.8

2026-01-011

PRE

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)

Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules

亲和捕获-洗脱结合细胞基环腺苷酸测定法，作为一种检测抑制素分子中和抗体的平台方法

The AAPS Journal

IF0

2025-10-130

PRE

Development of a long-acting relaxin analogue, LY3540378, for treatment of chronic heart failure

BRITISH JOURNAL OF PHARMACOLOGY

IF7.7

2023-03-0814

Verdino, Petra; Lee, Stacey L.; Cooper, Fariba N.; Cottle, Steven R.; Grealish, Patrick F.; Hu, Charlie C.; Meyer, Catalina M.; Lin, Joanne; Copeland, Victoria; Porter, Gina; Schroeder, Richard L.; Thompson, Tyran D.; Porras, Leah L.; Dey, Asim; Zhang, Hong Y.; Beebe, Emily C.; Matkovich, Scot J.; Coskun, Tamer; Balciunas, Aldona M.; Ferrante, Andrea; Siegel, Robert; Malherbe, Laurent; Bivi, Nicoletta; Paavola, Chad D.; Hansen, Ryan J.; Abernathy, Matthew M.; Nwosu, Sylvia O.; Carr, Molly C.; Heuer, Josef G.; Wang, Xiaojun

Safety and Immunogenicity of LY3415244, a Bispecific Antibody Against TIM-3 and PD-L1, in Patients With Advanced Solid Tumors

CLINICAL CANCER RESEARCH

IF10.2

2021-01-1370