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

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

FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

FDA批准摘要:Mobocertinib用于治疗EGFR 20号外显子插入突变的转移性非小细胞肺癌

Duke, Elizabeth S; Stapleford, Liza; Drezner, Nicole; Amatya, Anup K; Mishra-Kalyani, Pallavi S; Shen, Yuan-Li; Maxfield, Kimberly; Zirkelbach, Jeanne Fourie; Bi, Youwei; Liu, Jiang; Zhang, Xinyuan; Wang, Hezhen; Yang, Yuching; Zheng, Nan; Reece, Kelie; Wearne, Emily; Glen, Jacqueline J; Ojofeitimi, Idara; Scepura, Barbara; Nair, Abhilasha; Bikkavilli, Rama Kamesh; Ghosh, Soma; Philip, Reena; Pazdur, Richard; Beaver, Julia A; Singh, Harpreet; Donoghue, Martha

Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use

指导和政策在增强临床药理学在药物研发、监管和应用中的影响方面的作用

Madabushi, Rajanikanth; Pfuma Fletcher, Elimika; Florian, Jeffry; Milligan, Lauren; Ramamoorthy, Anuradha; Yang, Xinning; Maxfield, Kimberly; Sahre, Martina; Jean, Daphney; Zhang, Lei; Green, Dionna; Zineh, Issam

The Role of Public-Private Partnerships in Catalyzing the Critical Path

公私伙伴关系在催化关键路径中的作用

Maxfield, Kimberly E; Buckman-Garner, ShaAvhrée; Parekh, Ameeta

Multiple cancer testis antigens function to support tumor cell mitotic fidelity.

多种睾丸癌抗原的功能是支持肿瘤细胞有丝分裂的准确性

Cappell Kathryn M, Sinnott Rebecca, Taus Patrick, Maxfield Kimberly, Scarbrough Moriah, Whitehurst Angelique W

Thin-walled microvessels in human coronary atherosclerotic plaques show incomplete endothelial junctions relevance of compromised structural integrity for intraplaque microvascular leakage

人类冠状动脉粥样硬化斑块中的薄壁微血管显示出内皮细胞连接不完整,结构完整性受损与斑块内微血管渗漏密切相关

Sluimer, Judith C; Kolodgie, Frank D; Bijnens, Ann P J J; Maxfield, Kimberly; Pacheco, Erica; Kutys, Bob; Duimel, Hans; Frederik, Peter M; van Hinsbergh, Victor W M; Virmani, Renu; Daemen, Mat J A P