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

17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays

第十七届海湾合作委员会闭门论坛:整合生物分析、以患者为中心的采样、新兴技术、数据完整性、样本核对、ELISpot 数据差异、交叉验证协调、ADA 检测的超灵敏平台、远程监管评估、PCR 脱落检测和生物标志物组织检测

Zimmer, Jennifer; O'dell, Mark; Johnson, Derrick; Hays, Amanda; Gorityala, Shashank; Tary-Lehmann, Magdalena; Malone, Katherine; Diaz, Manisha; Xu, Tao; Dwivedi, Varun; Dufield, Dawn; Iles, Tracy; Sikkema, Daniel; Majumdar, Ritankar; Riccitelli, Nathan; Yuan, Moucun; Lowes, Steve; Liu, Aihua; Matys, Katie; Turksma, Annelies; Pirro, John; Bergeron, Jerome; Karnik, Shane; Voelker, Troy; Salha, Danielle; Reynolds, Gregory; Lamy, Corbyn; Yu, Mathilde; Garofolo, Wei; Nadarajah, Sankeetha; Leskovar, Amanda; Pellerin, Mario; Veeramachaneni, Rathna; Kane, Cheikh; Xu, Allan; Hyer, Elizabeth; Carlsson, Annika; Sanghvi, Mitesh; Dompkowski, Elizabeth; Rundlett, Stephen; Bower, Joseph; Spytko, Adriane; Liu, Jia; Gu, Weihua; Rocha, Agostinho; O'Brien, Kyla; Fang, Xinping

2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (Part 1A - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV)

2024 年生物分析最新问题白皮书:三向交叉验证;尿液临床分析;自动化方法;关于血浆蛋白结合的监管问询;自动化生物样本管理;ELN 迁移;超灵敏质谱(第 1A 部分 - 关于质谱分析、色谱、样品制备和 BMV/受监管生物分析的高级策略的建议;第 1B 部分 - 监管机构对受监管生物分析/BMV 的意见)

Wojcik, John; Sikorski, Timothy; Wang, Jian; Huang, Yue; Sugimoto, Hiroshi; Baratta, Mike; Ciccimaro, Eugene; Green, Rachel; Jian, Wenying; Kar, Sumit; Kim, Yeoun Jin; Lassman, Michael; Mohapatra, Susovan; Qian, Mark; Rosenbaum, Anton I; Sarvaiya, Hetal; Tian, Yu; Vainshtein, Inna; Yuan, Long; Tao, Lin; Ji, Allena; Kochansky, Christopher; Qiu, Haibo; Maes, Estelle; Chen, Lin-Zhi; Cooley, Megan; Dufield, Dawn; Hyer, Elizabeth; Johnson, Jay; Li, Wenkui; Liu, Aihua; Lu, Yang; Meissen, John; Palandra, Joe; Tang, Xiaonan; Vigil, Adam; Wei, Wei; Vinter, Stephen; Xue, Yongjun; Yang, Li; Zheng, Naiyu; Benson, Kimberly; McCush, Fred; Liang, Zhenmin; Abberley, Lee; Andisik, Matthew; Araya, Marcela; Cho, Seongeun Julia; Colligan, Liliana; Dasgupta, Arindam; Dudek, Markus; Edmison, Anna; Fischer, Sally; Folian, Brian; Garofolo, Fabio; Ishii-Watabe, Akiko; Ivanova, Dany; Gijsel, Sonja Kwadijk-de; Luo, Lina; McGuinness, Michael; 'Day, Christine O; Salehzadeh-Asl, Reza; Neto, João Tavares; Verhaeghe, Tom; Wan, Katty; Whale, Emma; Yan, Weili; Yang, Eric; Zhang, Jinhui

Recommendations on biomarker assay validation (BAV) in tissues by GCC

GCC关于组织中生物标志物检测验证(BAV)的建议

Yuan, Moucun; Liu, Aihua; Xu, Bin; Sales, Kurt; Karnik, Shane; Voelker, Troy; Salha, Danielle; Zimmer, Jennifer; O'Dell, Mark; Gorityala, Shashank; Hays, Amanda; Lester, Todd; Reynolds, Gregory; Tary-Lehmann, Magdalena; Yu, Mathilde; Roberge, Martin; Malone, Katherine; Patel, Vimal; Love, Iain; Lin, Jenny; Diaz, Manisha; Xu, Tao; Garofolo, Wei; McGregor, Jessica; Leskovar, Amanda; Kernstock, Robert; Pellerin, Mario; Brown, Michael; Spytko, Adriane; Lowes, Stephen; Ambrose, David; Dufield, Dawn; Kane, Cheikh; Veeramachaneni, Rathna; Luna, Marsha; Warrino, Dominic; Dwivedi, Varun; Xu, Allan; Hyer, Elizabeth; Iles, Tracy; Majumdar, Ritankar; Sikkema, Daniel; Thomas, Eric; Carlsson, Annika; Dakappagari, Naveen; Riccitelli, Nathan; Marco, Chantal Di; Bouhajib, Mohammed; Iordachescu, Adriana; Sanghvi, Mitesh; Barton, Hollie; Lavelle, Amy; Dompkowski, Elizabeth; Rundlett, Stephen; Matys, Katie; Sangster, Tim; Turksma, Annelies; Gu, Weihua; Liu, Jia; Hoffpauir, Brian; Rocha, Agostinho; Pirro, John; Bergeron, Jerome; O'Brien, Kyla; Fang, Xinping; Dong, Kelly; Yamashita, Jim

16(th) GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status

第十六届海湾合作委员会闭门论坛:ICH M10实施;NGS、qPCR/dPCR、流式细胞术验证;组织生物标志物;免疫原性响应;免疫原性协调;生物分析行业现状

Zimmer, Jennifer; Hays, Amanda; Lester, Todd; Diaz, Manisha; Thomas, Eric; O'Dell, Mark; Hyer, Elizabeth; Tangri, Shabnam; Dakappagari, Naveen; Yuan, Moucun; Lavelle, Amy; Karnik, Shane; Liu, Aihua; Xu, Bin; Sales, Kurt; Gorityala, Shashank; Reynolds, Gregory; Sangster, Tim; Franckaert, Dean; Love, Iain; Patel, Vimal; Roberge, Martin; Lin, Jenny; Jerks, Erik; Xu, Tao; Garofolo, Wei; Nadarajah, Sankeetha; Kernstock, Robert; Dufield, Dawn; Ambrose, David; Warrino, Dominic; Luna, Marsha; Marco, Chantal Di; Tudoroniu, Ariana; Iordachescu, Adriana; Sanghvi, Mitesh; Barton, Hollie; Brown, Michael; Hoffpauir, Brian; Rocha, Agostinho; Dong, Kelly; Yamashita, Jim

Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics

关于蛋白质生物治疗药物LC-MS/MS生物分析方法验证的建议

Jenkins, Rand; Duggan, Jeffrey X; Aubry, Anne-Françoise; Zeng, Jianing; Lee, Jean W; Cojocaru, Laura; Dufield, Dawn; Garofolo, Fabio; Kaur, Surinder; Schultz, Gary A; Xu, Keyang; Yang, Ziping; Yu, John; Zhang, Yan J; Vazvaei, Faye

Multiplex transcriptional analysis of paraffin-embedded liver needle biopsy from patients with liver fibrosis

对肝纤维化患者石蜡包埋肝穿刺活检标本进行多重转录组分析

Staten, Nicholas R; Welsh, Eric A; Sidik, Kurex; McDonald, Sandra A; Dufield, Dawn R; Maqsodi, Botoul; Ma, Yunqing; McMaster, Gary K; Mathews, Rodney W; Arch, Robert H; Masferrer, Jaime L; Souberbielle, Bernard E