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2025 White Paper on Recent Issues in Bioanalysis: What is the Future of Bioanalytical LIMS? AI/ML Integration in Bioanalysis; Tear Sample Collection; Radiolabeled Mass Balance Studies; Chiral Assays; Bioanalysis of Antibody-Oligonucleotide & Bicycle Drug Conjugates (PART 1A-Recommendations on Mass Spectrometry Assays, Chromatography, Sample Preparation and Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting PART 1B-Regulatory Agencies' Input on Regulated Bioanalysis/BMV) 2025年生物分析热点问题白皮书：生物分析实验室信息管理系统（LIMS）的未来是什么？人工智能/机器学习在生物分析中的应用；泪液样本采集；放射性标记质量平衡研究；手性分析；抗体-寡核苷酸与自行车药物偶联物的生物分析（第一部分A：关于质谱分析、色谱法、样品制备和受监管生物分析的采样、验证、分析与报告的建议；第一部分B：监管机构对受监管生物分析/桥接方法验证的反馈） Wojcik, John; Qian, Mark; Rosenbaum, Anton I.; Maes, Estelle; Xue, Yongjun; Kochansky, Christopher; Boer, Jason; Chen, Linzhi; Descloux, Sandrine; Garofolo, Fabio; Johnson, Jay; Kaur, Surinder; Lassman, Michael; Mcgregor, Jessica; O'callaghan, Lisa; Sikorski, Timothy; Wan, Katty; Wang, Shunhai; Zheng, Naiyu; Zhang, Guodong; Hoover, Michael; Wang, Jian; Yuan, Long; Ji, Qin; Jones, Barry; Boyanapalli, Ramakrishna; Chen, Jian; Dobson, Christine; Dong, Linlin; Ferrari, Luca; Fu, Yunlin; Gong, Chao; Ivanova, Dany; Li, Jing; Licea-Perez, Hermes; Liu, Aihua; Tang, Xiaonan; Tao, Lin; Tweed, Joseph; Eddy, John; Francis, Jennifer; Kavetska, Olga; Araya, Marcela; Foley, Timothy; Andisik, Matthew; Belfast, Mary; Borbridge, Lisa; Cho, Seongeun (julia); Colligan, Liliana; Dasgupta, Arindam; Edmison, Anna; Fandozzi, Christine; Galliccia, Fabrizio; Kim, Yeoun Jin; Lu, Yang; Massip, Anne-Marie; Shakleya, Diaa; Tampal, Nilufer; Neto, Joao Tavares; Thomas, Justina; Wang, Jin; Wang, Linna; Wang, Ying; Whale, Emma; Wiberg, Megan; Yang, Li 分享 收藏
A dual diacylglycerol kinase (DGK) alpha/zeta inhibitor augments the activity of human tumor infiltrating lymphocytes in in vivo and ex vivo models 双甘油二酯激酶 (DGK) α/zeta抑制剂在体内和离体模型中增强了人类肿瘤浸润淋巴细胞的活性 Areesawangkit, Phurin; Fong, Karen Pei-Yi; Niemeyer, Emma; Li, Yan; Markowitz, Kelly; Delman, Devora; Krause, Ryan; Carl, Justine; Feldman, Pat; Troung, Lisa; Hess, Rodrigo; Ren, Xiaodi; Timmers, Cynthia; Kim, Sunkyu; Brody, Robert; Singhal, Sunil; Predina, Jarrod; Eruslanov, Evgeniy; Beatty, Gregory; Melidosian, Bihui; Albelda, Steven M. 分享 收藏
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 Biomarker Assay Validation (BAV)) 2025年生物分析近期问题白皮书：生物标志物校准与稳定性；NULISA评估；神经丝蛋白与自身抗体生物标志物检测；去除IgM干扰；ELISpot与FluoroSpot最佳实践；模块化高维度细胞计数；单细胞分析成像细胞计数（第二部分A-关于生物标志物发现、开发、验证与监管批准、配体结合检测（LBA）和细胞基础检测（CBA）的建议；第二部分B-监管机构对生物标志物、体外诊断（IVD）/伴随诊断（CDx）和生物标志物检测验证（BAV）的反馈） 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; Tavares Neto, Joao; 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; O'Connor, Ellen; 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) 分享 收藏
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Guided Sample Pooling in Human Mass Balance Studies: A Recommended Strategic Decision Framework Cuyckens, Filip; Li, Wenying; Auclair, Adam M.; Cassidy, Kenneth C.; Cantalloube, Cathy; Collins, Gary; James, Alexander D.; Gibson, Chris; Glaenzel, Ulrike; Huth, Felix; Kang, Ping; Moliner, Patricia; Pedersen, Mette L.; Piel, Isabel; Brunetti, Pietro; Schieferstein, Hanno; Wagner, David; Walker, Gregory S.; Wang, Shuai; Yue, Qin; Boer, Jason; Khojasteh, Cyrus 分享 收藏
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First-in-human phase I open-label study of the anti-TIM-3 monoclonal antibody INCAGN02390 in patients with select advanced or metastatic solid tumors INCAGN02390抗-TIM-3单克隆抗体在选择性晚期或转移性实体瘤患者中的首次人体I期开放标签研究 Gutierrez, Martin E.; Tang, Shou-Ching; Powderly, John D.; Balmanoukian, Ani S.; Hoyle, Paul E.; Dong, Zhiwan; Cheng, Lulu; Gong, Xiaohua; Janik, John E.; Bourayou, Nawel; Hamid, Omid 分享 收藏
First-in-human phase I open-label study of the LAG-3 antagonist antibody INCAGN02385 in patients with select advanced or metastatic solid tumors 首次人体I期开放标签研究：LAG-3拮抗剂抗体INCAGN02385在特定晚期或转移性实体瘤患者中的应用 Powderly II, John D.; Gutierrez, Martin E.; Balmanoukian, Ani S.; Hoyle, Paul E.; Dong, Zhiwan; Cheng, Lulu; Chen, Xuejun; Janik, John E.; Bourayou, Nawel; Hamid, Omid 分享 收藏
Nonclinical teratogenicity safety assessment of CRBN-engaging targeted protein degraders: Points to consider Loberg, Lise I.; Proctor, William R.; Burdick, Andrew D.; Cauvin, Annick; Delise, Anthony M.; Hemkens, Michelle; Hohlbaum, Andreas M.; Hukkanen, Renee; Sedgwick, Alanna E.; Shuey, Dana; Zane, Doris T.; Stamp, Katie 分享 收藏
Semimechanistic Population PK/PD Modeling of Axatilimab in Healthy Participants and Patients With Solid Tumors or Chronic Graft-Versus-Host Disease Yang, Yan-ou; Sokolov, Victor; Volkova, Alina; Liu, Xing; Leon, Cristina; Kosinsky, Yuri; Barker, Breann; Zhang, Xuecheng; Ordentlich, Peter; Sheng, Jennifer; Chen, Xuejun 分享 收藏
Opportunities and challenges for use of minipigs in nonclinical pharmaceutical development: Results of a follow-up IQ DruSafe survey Clarke, David O.; Datta, Kaushik; French, Kevin; Leach, Michael W.; Olaharski, Drew; Mohr, Susanne; Strein, Devon; Bussiere, Jeanine; Feyen, Bianca; Gauthier, Beatrice E.; Graziano, Michael; Harding, Joanna; Hershman, Kenneth; Jacob, Binod; Ji, Shaofei; Lange, Robert; Salian-Mehta, Smita; Sayers, Brian; Thomas, Nicole; Flandre, Thierry 分享 收藏
POD1UM-304: Phase III study of retifanlimab plus platinum-based chemotherapy (Chemo) as first-line (1L) therapy for nonsquamous or squamous metastatic nonesmall cell lung cancer (mNSCLC) POD1UM-304：瑞他法尼单抗联合铂类化疗（Chemo）作为非鳞状或鳞状转移性非小细胞肺癌（mNSCLC）的一线（1L）治疗的III期研究 Lu, S.; Vynnychenko, O.; Kulyaba, Y.; Kuchava, V.; Ibrahim, A.; Moiseenko, F. V.; Arslan, C.; Nguyen, D. T.; Zhang, M.; Petrovic, M. D.; Cicin, I.; Bibichadze, K.; Cil, T.; Cornfeld, M.; Tian, C.; Munteanu, M.; Sette, C. V. D. M.; Bondarenko, I. 分享 收藏
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