Nowatzke William, Cole Thomas G, Bowsher Ronald R
CEDRA Corporation, 8609 Cross Park Drive, Austin, TX 78660, USA.
Bioanalysis. 2010 Feb;2(2):237-47. doi: 10.4155/bio.09.191.
The use of biomarkers during clinical drug-development programs may expedite pipeline decision making by adding critical information about the pharmacological mechanism and efficacy of a potential therapeutic agent. Currently, advice for laboratorians conducting method development and analytical validation of biomarker methods is provided by published White Paper recommendations from industry thought leaders. The adaptation of commercial test kits to generate biomarker data to support regulated studies offers unique challenges and limitations. In this perspective, we address these issues, including factors to consider when identifying a kit manufacturer and adapting commercial test kits for use in regulated studies. We offer a logical and systematic approach for defining the extent of analytical validation needed for application of commercial kits based upon the intended use of the biomarker data.
在临床药物研发项目中使用生物标志物，可通过补充有关潜在治疗药物药理机制和疗效的关键信息，加快管线决策。目前，行业思想领袖发布的白皮书建议为实验室人员开展生物标志物方法的方法开发和分析验证提供了指导。采用商业检测试剂盒生成生物标志物数据以支持规范研究面临着独特的挑战和限制。从这个角度出发，我们探讨了这些问题，包括在选择试剂盒制造商以及使商业检测试剂盒适用于规范研究时需要考虑的因素。我们提供了一种逻辑且系统的方法，可根据生物标志物数据的预期用途来确定应用商业试剂盒所需的分析验证程度。
