日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

IQ Survey Results on Current Industry Practices-Part 1: Immunogenicity Risk Assessment

IQ调查结果:当前行业实践——第一部分:免疫原性风险评估

Grimaldi, Christine; Richards, Susan; Baltrukonis, Daniel; Sims Belouski, Shelley; Coble, Kelly; Dholakiya, Sanjay L; Grudzinska-Goebel, Joanna; Kolaitis, Gerry; Leu, Jocelyn H; Luo, Linlin; Lowe, Stephen; Niu, Tao; Toft-Hansen, Henrik; Yang, Jianning; Wu, Benjamin

Children in Mental Health Crisis: Pediatric Primary Care Providers' Role in Bridging Treatment Following Higher Levels of Care

儿童心理健康危机:儿科初级保健提供者在衔接更高层级护理后的治疗中的作用

Ferro, Rebecca A; Edwards, Sarah; Coble, Kelly; Riddle, Mark; Reinblatt, Shauna P; Ader, Chelsie; Crosby Budinger, Meghan; Bettencourt, Amie F

Method development for the detection of anti-drug antibodies against a therapeutic peptide: assay format selection

针对治疗性肽的抗药抗体检测方法开发:检测形式的选择

Chen, Fangfang; He, Xiaolong; Mao, Yan; Coble, Kelly

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

2025 年生物分析最新问题白皮书:生物标志物校准品和稳定性;核素标记免疫球蛋白结合免疫球蛋白 (NULISA) 的评估;神经丝和自身抗体生物标志物检测;消除 IgM 干扰;酶联免疫斑点 (ELISpot) 和荧光斑点 (FluoroSpot) 最佳实践;模块化高清流式细胞术;单细胞分析成像流式细胞术(第二部分 A - 关于生物标志物发现、开发、验证和监管审批、配体结合分析 (LBA) 和基于细胞的分析 (CBA) 的建议;第二部分 B - 监管机构对生物标志物、体外诊断/伴随诊断 (IVD/CDx) 的意见)

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; Neto, Joao Tavares; 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; Connor, Ellen O'; 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

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (PART 2A - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)

2024 年生物分析最新议题白皮书:美国实验室自建检测 (LDT) 和欧盟体外诊断医疗器械法规 (IVDR) 的影响;高参数流式细胞术的 AI/ML;Olink 技术的崛起;腺相关病毒 (AAV) 基因疗法的伴随诊断 (CDx);多平台整合生物分析;超灵敏 ADA/NAb 配体结合分析 (LBA)(第二部分 A - 生物标志物、体外诊断/伴随诊断检测 (BAV)、细胞检测 (CBA) 和配体结合分析 (LBA) 的高级策略建议;第二部分 B - 监管机构对生物标志物、体外诊断/伴随诊断和生物标志物检测验证的意见)

Bivi, Nicoletta; Graham, Danielle; Joglekar, Laura; McGuire, Kristina; Stoop, Jeroen; Zoghbi, Jad; Baker, Brian; Bandukwala, Abbas; Bond, Sarah; Buoninfante, Alessandra; Chen, Jeff; Dysinger, Mark; Engelbergs, Jörg; Fiscella, Michele; Garofolo, Fabio; Hopper, Shirley; Jones, Barry; King, Lindsay; Murphy, Rocio; Palmer, Rachel; Sanderink, Gerard; Seyda, Agnes; Tang, Huaping; Van Tuyl, Andrea; Wagner, Leslie; Walravens, Karl; Wang, Kai; Zander, Hilke; Zhu, Liang; Li, Ming; Lin, Yi-Dong; Natalia, Mahwish; Standifer, Nathan; Eck, Steven; Goihberg, Polina; Grugan, Katharine; Hedrick, Michael Nathan; Hopkins, Greg; Kar, Sumit; Keller, Steve; McGrath, Shannon; O'Gorman, Bill; Stevens, Chad; Stevens, Erin; Terszowski, Grzegorz; Trampont, Paul C; Yao, Shuyu; Joyce, Alison; Kumar, Seema; Owen, Carolina; Pine, Samuel; Yearwood, Graham; Cao, Liching; Clausen, Valerie; Coble, Kelly; Culbert, Andria; Gupta, Shalini; Hughes, Richard; Liu, Susana; Lu, Kun; Martello, Rita; Reese, Kimberly J; Stubenrauch, Kay-Gunnar; Wen, Yi

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)

2023 年生物分析最新问题白皮书:ADA 检测的 ISR、dPCR 与 qPCR 的兴起、疫苗检测的国际参考标准、抗 AAV TAb 给药后评估、NanoString 验证、ELISpot 作为金标准(第三部分 - 关于基因治疗、细胞治疗、疫苗免疫原性和技术的建议;生物治疗免疫原性和风险评估;ADA/NAb 检测/报告协调)

Mora, Johanna; Palmer, Rachel; Wagner, Leslie; Wu, Bonnie; Partridge, Michael; Meena; Sonderegger, Ivo; Smeraglia, John; Bivi, Nicoletta; Dakappagari, Naveen; Diebold, Sandra; Garofolo, Fabio; Grimaldi, Christine; Kalina, Warren; Kamerud, John; Kar, Sumit; Marshall, Jean-Claude; Mayer, Christian; Melton, Andrew; Merdek, Keith; Nolan, Katrina; Picard, Serge; Shao, Weiping; Seitzer, Jessica; Tanaka, Yoichi; Tounekti, Omar; Vigil, Adam; Walravens, Karl; Xu, Joshua; Xu, Weifeng; Xu, Yuanxin; Yang, Lin; Zhu, Liang; Verthelyi, Daniela; Kubiak, Robert J; Coble, Kelly; Gupta, Swati; Abhari, Mohsen Rajabi; Richards, Susan; Song, Yuan; Ullmann, Martin; Calderon, Boris; Cludts, Isabelle; Gunn, George R; Gupta, Shalini; Ishii-Watabe, Akiko; Manangeeswaran, Mohanraj; Maxfield, Kimberly; McCush, Fred; O'Day, Christine; Peng, Kate; Poetzl, Johann; Rasamoelisolo, Michele; Saad, Ola M; Scheibner, Kara; Shubow, Sophie; Song, Sam; Thacker, Seth

Program development and implementation outcomes of a statewide addiction consultation service: Maryland Addiction Consultation Service (MACS)

全州成瘾咨询服务项目开发和实施成果:马里兰州成瘾咨询服务 (MACS)

Sweeney, Sarah; Coble, Kelly; Connors, Elizabeth; Rebbert-Franklin, Kathleen; Welsh, Christopher; Weintraub, Eric

Retrospective analysis of model-based predictivity of human pharmacokinetics for anti-IL-36R monoclonal antibody MAB92 using a rat anti-mouse IL-36R monoclonal antibody and RNA expression data (FANTOM5).

使用大鼠抗小鼠 IL-36R 单克隆抗体和 RNA 表达数据 (FANTOM5) 对抗 IL-36R 单克隆抗体 MAB92 的人体药代动力学进行基于模型的预测的回顾性分析

Ahlberg Jennifer, Giragossian Craig, Li Hua, Myzithras Maria, Raymond Ernie, Caviness Gary, Grimaldi Christine, Brown Su-Ellen, Perez Rocio, Yang Danlin, Kroe-Barrett Rachel, Joseph David, Pamulapati Chandrasena, Coble Kelly, Ruus Peter, Woska Joseph R, Ganesan Rajkumar, Hansel Steven, Mbow M Lamine

Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran

在需要紧急逆转达比加群抗凝作用的患者中,伊达鲁西珠单抗及其靶标达比加群的药代动力学

Glund, Stephan; Coble, Kelly; Gansser, Dietmar; Stangier, Joachim; Hoermann, Karin; Pollack, Charles V; Reilly, Paul