Recommendations for the validation of flow cytometric testing during drug development: II assays
Recommendations for the validation of flow cytometric testing during drug development: II assays
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DOI：
10.1016/j.jim.2010.09.036
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发表时间：
2011-01-05
影响因子：
2.2
通讯作者：
Litwin, Virginia
中科院分区：
文献类型：
--
作者：
O'Hara, Denise M.;Xu, Yuanxin;Litwin, Virginia
基于流式细胞术的分析是药物开发过程的各个方面的有价值的工具，从靶点发现和表征到临床环境中反应的评估。样品的完整性以及在这些测定中使用的试剂的适当选择和表征本身就具有挑战性。这些问题与基于流动的技术一起使流式细胞术分析的验证成为一项具有挑战性的工作。因此，除了总结流式细胞术技术在药物开发各个阶段的作用外，本文还重点介绍了流式细胞术应用方法验证的建议。还提供了不同类型流式细胞术检测的相关验证参数的信息，以指导该平台的用户。总之，本文提供的建议和监管指南信息代表了所有作者的共识，可以帮助流式细胞术用户实施适当的方法验证策略。(C) 2010 Elsevier B.V.版权所有
Flow cytometry-based assays serve as valuable tools for various aspects of the drug development process ranging from target discovery and characterization to evaluation of responses in a clinical setting. The integrity of the samples and the appropriate selection and characterization of the reagents used in these assays are in themselves challenging. These concerns taken together with the flow-based technology makes the validation of flow cytometry assays a challenging effort. Therefore, apart from summarizing the role of flow cytometry technology in various stages of drug development, this manuscript focuses on recommendations for the validation of methods applying flow cytometry. Information is also provided on the relevant validation parameters for different types of flow cytometry assays to guide the users of this platform. Together, the recommendations and the information on regulatory guidelines provided in this manuscript represent the consensus of all the authors and can assist the flow cytometry user in implementing the appropriate method validation strategies. (C) 2010 Elsevier B.V. All rights reserved.