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药效学生物标志物流式细胞术方法的开发与验证

Development and validation of flow cytometry methods for pharmacodynamic clinical biomarkers.

作者信息

Wu Dianna Y, Patti-Diaz Lisa, Hill Carla G

机构信息

Bristol-Myers Squibb Company, 311 Pennington-Rocky Hill Road, Mail Stop 3B-201, Pennington, NJ 08534, USA.

出版信息

Bioanalysis. 2010 Sep;2(9):1617-26. doi: 10.4155/bio.10.33.

DOI:10.4155/bio.10.33
PMID:21083290
Abstract

Flow cytometry is a powerful analytical tool for the analysis of multiple biological parameters of individual cells or particles within heterogeneous cell populations. It has been widely used in biomedical research to perform immunophenotyping, cell counting and numerous cell function assessments, such as intracellular cytokine production, protein phosphorylation, cell proliferation and apoptosis. The implementation of standardized flow cytometry-based biomarker assays in clinical trials remains a challenge due to the limited stability of clinical specimens and the technical variations between instruments. To ensure data quality, it is crucial to develop robust assays for clinical applications. In this review, we summarize current practice in developing, validating and implementing flow cytometry assays to evaluate biomarkers in clinical research.

摘要

流式细胞术是一种强大的分析工具,用于分析异质细胞群体中单个细胞或颗粒的多种生物学参数。它已广泛应用于生物医学研究,以进行免疫表型分析、细胞计数和众多细胞功能评估,如细胞内细胞因子产生、蛋白质磷酸化、细胞增殖和凋亡。由于临床样本稳定性有限以及仪器之间的技术差异,在临床试验中实施基于流式细胞术的标准化生物标志物检测仍然是一项挑战。为确保数据质量,开发适用于临床应用的可靠检测方法至关重要。在本综述中,我们总结了目前在开发、验证和实施流式细胞术检测以评估临床研究中的生物标志物方面的实践。

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1
Development and validation of flow cytometry methods for pharmacodynamic clinical biomarkers.药效学生物标志物流式细胞术方法的开发与验证
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Flow cytometry and cell sorting.流式细胞术和细胞分选。
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Recommendations for the validation of flow cytometric testing during drug development: II assays.流式细胞术检测在药物研发中的验证建议:二、检测方法。
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Validation of a flow cytometry based G(2)M delay cell cycle assay for use in evaluating the pharmacodynamic response to Aurora A inhibition.基于流式细胞术的 G(2)/M 期延迟细胞周期检测方法的验证,用于评估 Aurora A 抑制的药效反应。
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Cellometer vision as an alternative to flow cytometry for cell cycle analysis, mitochondrial potential, and immunophenotyping.细胞仪视觉作为流式细胞术的替代方法,用于细胞周期分析、线粒体潜能和免疫表型分析。
Cytometry A. 2011 Jul;79(7):507-17. doi: 10.1002/cyto.a.21071. Epub 2011 Apr 29.
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Analysis of protein phosphorylation and cellular signaling events by flow cytometry: techniques and clinical applications.通过流式细胞术分析蛋白质磷酸化和细胞信号传导事件:技术与临床应用
Clin Immunol. 2004 Mar;110(3):206-21. doi: 10.1016/j.clim.2003.11.009.
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From research to regulated: challenges in transferring methods.从研究到规范:方法转化中的挑战。
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Flow cytometry: an overview.流式细胞术:概述。
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Flow cytometry in preclinical drug development.临床前药物研发中的流式细胞术。
Methods Mol Biol. 2010;598:303-21. doi: 10.1007/978-1-60761-401-2_21.
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Intracellular phospho-protein staining techniques for flow cytometry: monitoring single cell signaling events.用于流式细胞术的细胞内磷酸化蛋白染色技术:监测单细胞信号转导事件
Cytometry A. 2003 Oct;55(2):61-70. doi: 10.1002/cyto.a.10072.

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Comparison of a microsphere-based platform with a multiplex flow cytometric assay for determination of circulating cytokines in the mouse.基于微球的平台与多重流式细胞术检测法在小鼠循环细胞因子测定中的比较。
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