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

The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring.

世界卫生组织首个英夫利昔单抗抗药抗体参考小组:朝着统一治疗药物监测迈出的一步

Wadhwa Meenu, Cludts Isabelle, Atkinson Eleanor, Rigsby Peter

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)

2023 年生物分析最新问题白皮书:欧盟 IVDR 2017/746 的实施/影响、体外诊断/伴随诊断/CLIA 批准的检测方法、高维细胞术、多重分析技术、LBA 组织分析、疫苗研究终点、用于生物标志物的细胞检测、细胞疗法和疫苗(第二部分 - 关于生物标志物、体外诊断、伴随诊断、细胞检测、流式细胞术、配体结合和酶检测的开发和验证的建议;先进关键试剂策略)

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; Du, Xiulian; Goihberg, Polina; Alcaide, Enrique Gomez; Gonneau, Christele; Hedrick, Michael Nathan; Hopkins, Gregory; Kar, Sumit; 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

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

2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunog

2023年生物分析最新问题白皮书:氘代药物;脂质纳米颗粒;肿瘤/FFPE活检;靶向蛋白质组学;小分子共价抑制剂;手性生物分析;远程监管评估;样品核对/监管链(第一部分A - 关于质谱、色谱、样品制备的最新进展、挑战和解决方案以及BMV/受监管生物分析的建议;第一部分B - 监管机构对受监管生物分析/BMV、生物标志物/体外诊断/伴随诊断/生物活性物质、免疫学的意见)

Baratta, Mike; Jian, Wenying; Hengel, Shawna; Kaur, Surinder; Cunliffe, Jennifer; Boer, Jason; Hughes, Nicki; Kar, Sumit; Kellie, John; Kim, Yeoun Jin; Lassman, Michael; Mehl, John; Morgan, Ling; Palandra, Joe; Sarvaiya, Hetal; Zeng, Jianing; Zheng, Naiyu; Wang, Jian; Yuan, Long; Ji, Allena; Kochansky, Christopher; Tao, Lin; Huang, Yue; Maes, Estelle; Barbero, Luca; Contrepois, Kevin; Ferrari, Luca; Fu, Yunlin; Johnson, Jay; Jones, Barry; Kansal, Monika; Lu, Yang; Post, Noah; Shen, Honglue Holly; Xue, Yongjun Y-J; Zhang, Yiyue Cynthia; Biswas, Gopa; Cho, Seongeun Julia; Edmison, Anna; Benson, Kimberly; Abberley, Lee; Azadeh, Mitra; Francis, Jennifer; Garofolo, Fabio; Gupta, Shalini; Ivanova, Iordanka Dany; Ishii-Watabe, Akiko; Karnik, Shane; Kassim, Sean; Kavetska, Olga; Keller, Steve; Kossary, Elham; Li, Wenkui; McCush, Fred; Mendes, Dulcyane Neiva; Abhari, Mohsen Rajabi; Scheibner, Kara; Sikorski, Timothy; Staack, Roland F; Tabler, Edward; Tang, Huaping; Wan, Katty; Wang, Yow-Ming; Whale, Emma; Yang, Li; Zimmer, Jennifer; Bandukwala, Abbas; Du, Xiulian; Kholmanskikh, Olga; Gijsel, Sonja Kwadijk-de; Wadhwa, Meenu; Xu, Joshua; Buoninfante, Alessandra; Cludts, Isabelle; Diebold, Sandra; Maxfield, Kimberly; Mayer, Christian; Pedras-Vasconcelos, Joao; Abhari, Mohsen Rajabi; Shubow, Sophie; Tanaka, Yoichi; Tounekti, Omar; Verthelyi, Daniela; Wagner, Leslie