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

Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform

针对生物治疗药物研发过程中的免疫原性风险评估,制定个性化缓解措施并进行监测:欧洲免疫原性平台的建议

Grudzinska-Goebel, Joanna; Benstein, Karin; Bloem, Karien; Cowan, Kyra J; Gorovits, Boris; Jadhav, Maria; Janssen, Melody; Jawa, Vibha; Kiessling, Andrea; Kramer, Daniel; Kromminga, Arno; van der Linden, Marcel; Liu, Susana; Lotz, Gregor P; Luo, Linlin; Malisauskas, Mantas; Marban-Doran, Céline; Mytych, Daniel T; Oquendo Cifuentes, Elisa; Pippig, Susanne; Ribes, Sandra; Rouwette, Myrthe; Shao, Weiping; Tourdot, Sophie; Weldingh, Karin Nana; Snoeck, Veerle

Unlocking the Complexity of Antibody-Drug Conjugates: A Cutting-Edge LC-HRMS Approach to Refine Drug-to-Antibody Ratio Measurements with Highly Reactive Payloads.

揭开抗体-药物偶联物的复杂性:利用高反应性有效载荷改进药物与抗体比率测量的尖端 LC-HRMS 方法

Di Ianni Andrea, Cowan Kyra J, Riccardi Sirtori Federico, Barbero Luca

Bioanalysis Rising Star Award 2025: interviews with the finalists

2025年生物分析新星奖:决赛入围者访谈

Goodman, Joanne; Cowan, Kyra J; Golob, Michaela; Nelson, Robert; Baltrukonis, Daniel; Bloem, Karien; Butsel, Brendy Van; Champion, Lysie; Cook, John; Dang, Minh; Galeva, Desislava; Guerrieri, Davide; Jordan, Gregor; Krantz, Carsten; Lai, Ching-Hai; Roch, Toralf; Soares de Sonza, Adriano Luis; Stevenson, Lauren; Tosar, Luis Perez; Venema, Foka; Widmaier, Hanna; Timmerman, Philip; Jain, Abhishek; Rodriguez, Alejandro; Smythers, Amanda; Williams, Ellen

European Bioanalysis Forum recommendation on embracing a context-of-use-driven scientific validation for chromatographic assays in the light of ICH M10

欧洲生物分析论坛建议根据ICH M10指南,采用基于使用情境的科学验证方法对色谱分析进行验证。

Timmerman, Philip; McDougall, Stuart; Adcock, Neil; Arfvidsson, Cecilia; Barfield, Matthew; Blech, Stefan; Cowan, Kyra J; Ferrari, Luca; Greco, Alessandro; Golob, Michaela; Goodwin, Lee; Hughes, Richard; Ivanova, Tsvetelina; Laurén, Anna; Nelson, Robert; Neitzel, Sonja; Verhaeghe, Tom; van de Merbel, Nico; Wright, Mike; White, Stephen

Use of surrogate matrices in bioanalytical preclinical safety testing using immunoassay methods: a recommendation from the European Bioanalysis Forum

欧洲生物分析论坛关于在采用免疫分析方法进行生物分析临床前安全性测试中使用替代基质的建议

Hughes, Richard; Jordan, Gregor; Katterle, Yvonne; Jaitner, Birgit; Britten, Charles; Gerritsen, Arnout; Bandi, Deepa Reddy; Haslberger, Tobias; van Boekel, Tinie; Sigh, Jens; Golob, Michaela; Cowan, Kyra J; Timmerman, Philip

Evolving bioanalytical strategies in the wake of pioneering biotherapeutics

随着开创性生物疗法的出现,生物分析策略也在不断发展。

Riccardi Sirtori, Federico; Di Ianni, Andrea; Crosasso, Claudio; Bertotti, Elisa; Molinaro, Francesco; De Salve, Ilse; Barbero, Luca; Cowan, Kyra J

Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum

近期,欧洲生物分析论坛就挑战三级免疫原性检测策略展开了讨论并提出了相关建议。

Cowan, Kyra J; Bloem, Karien; Coddens, Annelies; Creed, Laura; Higgins, Hannah; Novoa, Jonathan Jimenez; Jones, Christopher; Katterle, Yvonne; Klinge, Marco; Leatherdale, Ben; Jaitner, Birgit; van Bommel, Peter; van der Lee, Saskia; Golob, Michaela; Nelson, Rob; Timmerman, Philip

The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays

欧洲生物分析论坛关于在抗药物抗体检测中建立适当药物耐受水平的建议

Cowan, Kyra J; Champion, Lysie; Dyer, Daniel; Carlsen, Morten Funch; Geary, Laura; Genin, Jean-Christophe; Golob, Michaela; Goodman, Joanne; Kromminga, Arno; Nelson, Rob; Revell, Heather; Rieger, Martin; Van de Vyver, Ortwin; Venema, Foka; Timmerman, Philip

A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays

欧洲生物分析论坛建议,为成功开发和验证生物标志物检测方法,必须提供使用背景说明。

Cowan, Kyra J; Kunz, Ulrich; Blattmann, Peter; Gulati, Pratiksha; Hughes, Richard; Andersen, Lene; Goodman, Joanne; Lambert, Frazer; Lawrence, James; Thwaites, Daniel; Golob, Michaela; Nelson, Robert; Timmerman, Philip

Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor

抗PD-L1单克隆抗体(一种免疫检查点抑制剂)的临床前药代动力学、药效学、组织分布和肿瘤渗透性

Deng, Rong; Bumbaca, Daniela; Pastuskovas, Cinthia V; Boswell, C Andrew; West, David; Cowan, Kyra J; Chiu, Henry; McBride, Jacqueline; Johnson, Clarissa; Xin, Yan; Koeppen, Hartmut; Leabman, Maya; Iyer, Suhasini