Delivery of high-quality biomarker assays.
Delivery of high-quality biomarker assays.
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DOI：
10.1155/2002/212987
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发表时间：
2002
期刊：
影响因子：
--
通讯作者：
Swanson BN
中科院分区：
文献类型：
--
作者：
Swanson BN
生物标志物测量现在支持整个药物开发过程中的关键决策，从先导物优化到监管批准。它们对于记录暴露-反应关系、针对分子靶点的特异性和效力、不良影响和治疗应用是必不可少的。从更广泛的意义上说，生物标志物构成了临床病理学和检验医学的基础。生物标志物的效用受到其对药物或疾病过程的特异性和敏感性以及总体可变性的限制。理解和控制变异的来源不仅对提供高质量的分析结果是必要的，而且最终对控制研究的规模和费用也是必要的。生物标志物测量的可变性受以下因素影响：生物和环境因素（如性别、年龄、姿势、饮食和生物节律）、样品收集因素（如防腐剂、运输和储存条件以及收集技术）和分析因素（如参比物质纯度、移液精度和抗体特异性）。用于支持非临床安全性研究的生物标志物检测的质量标准属于GLP （FDA）法规，而用于支持人类诊断和医疗保健的检测则由CLIA （CMS）法规和认证组织（如美国病理学家学院）建立。虽然大多数生物标志物的研究应用没有受到监管，但所有环境中的生物标志物实验室都采用类似的实验室实践，以提供高质量的数据。由于对生物标记物测量的需求不断增加，推动基因组学兴起的高度并行（多路复用）分析平台可能会演变成驱动未来生物标记物实验室的分析引擎。
Biomarker measurements now support key decisions throughout the drug development process, from lead optimization to regulatory approvals. They are essential for documenting exposure-response relationships, specificity and potency toward the molecular target, untoward effects, and therapeutic applications. In a broader sense, biomarkers constitute the basis of clinical pathology and laboratory medicine. The utility of biomarkers is limited by their specificity and sensitivity toward the drug or disease process and by their overall variability. Understanding and controlling sources of variability is not only imperative for delivering high-quality assay results, but ultimately for controlling the size and expense of research studies. Variability in biomarker measurements is affected by: biological and environmental factors (e.g., gender, age, posture, diet and biorhythms), sample collection factors (e.g., preservatives, transport and storage conditions, and collection technique), and analytical factors (e.g., purity of reference material, pipetting precision, and antibody specificity). The quality standards for biomarker assays used in support of nonclinical safety studies fall under GLP (FDA) regulations, whereas, those assays used to support human diagnostics and healthcare are established by CLIA (CMS) regulations and accrediting organizations such as the College of American Pathologists. While most research applications of biomarkers are not regulated, biomarker laboratories in all settings are adopting similar laboratory practices in order to deliver high-quality data. Because of the escalation in demand for biomarker measurements, the highly-parallel (multi-plexed) assay platforms that have fueled the rise of genomics will likely evolve into the analytical engines that drive the biomarker laboratories of tomorrow.
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影响因子：
--
作者：
Cravchik, A;Subramanian, G;Venter, JC
通讯作者：
Venter, JC
影响因子：
5
作者：
Goldie, DJ
通讯作者：
Goldie, DJ
影响因子：
5
作者：
Huisman, W
通讯作者：
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影响因子：
5
作者：
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通讯作者：
Blair, C
影响因子：
4.4
作者：
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通讯作者：
Grönroos, PE