| 利妥昔及其生物类似药在生物样品中的定量分析技术进展 |
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| 引用本文： | 侯利平,颜钰阳,李蠡,阳剑波,欧阳冬生.利妥昔及其生物类似药在生物样品中的定量分析技术进展[J].中国临床药理学与治疗学,2021(1). |
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| 作者姓名： | 侯利平 颜钰阳 李蠡 阳剑波 欧阳冬生 |
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| 作者单位： | 长沙都正医学检验有限责任公司;复杂基质样本生物分析湖南省重点实验室;美国明尼苏达大学医学院检验医学与病理学系;美国明尼苏达大学医学院耳鼻喉科;中南大学湘雅医院临床药理研究所 |
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| 基金项目： | 国家科技重大专项基于药物基因组学的示范性新药临床评价技术平台建设(2017ZX090361);湖南省重点实验室(2017TP1037);国际科技创新合作基地(2019CB1014);药物临床评价关键技术创新及应用示范(2019SK2241);基于信息化平台与智能计算的药物评价创新技术开发与应用(2019GK5020);长沙市科技计划项目(kh1902002)。 |
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| 摘 要： | 利妥昔是当前主要的单抗靶向治疗药物,伴随着越来越多的相关生物类似药临床评价需求,对于开发快速有效的定量方法来分析生物基质中利妥昔及其生物类似药提出了更高要求。本文综述了配体结合法、液质联用技术以及新兴定量技术检测该品种血药浓度的应用,供分析测试人员在开发利妥昔等单抗药物定量方法时参考。
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| 关 键 词： | 利妥昔 生物类似药 配体结合法 液质联用 免疫原性 |
Development of quantitative analysis methods of Rituximab and it's biosimilar in biological samples |
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| Institution: | (Changsha DUXACT Co.,Ltd.,Changsha 410000,Hunan,China;Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples,Changsha 410000,Hunan,China;Department of Laboratory Medicine and Pathology,Medical School,University of Minnesota,Minneapolis 55401,Minnesota,America;Department of Otolaryngology,Medical School,University of Minnesota,Minneapolis 55401,Minnesota,America;Department of Clinical Pharmacology,Xiangya Hospital,Central South University,Changsha 410000,Hunan,China) |
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| Abstract: | Rituximab is the main monoclonal antibody for targeted therapy currently.With more rituximab biosimilars appearing and clinical evaluation need increasing,it is crucial to develop rapid and effective quantitative methods to determine the rituximab blood concentration in biological matrices for drug metabolism and pharmacokinetics(DMPK)analysis.This article reviewed the application of ligand binding method(LBA),liquid chromatography-tandem mass spectrometry(LC-MS/MS)and emerging quantitative technology to detect the blood concentration of Rituximab,which may provide valuable information for the analysts and testers when developing quantitative methods for rituximab and its biosimilars. |
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| Keywords: | rituximab biosimilar LBA LC-MS/MS immunogenicity |
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