The current status of biomarkers for predicting toxicity.
The current status of biomarkers for predicting toxicity.
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DOI：
10.1517/17425255.2013.827170
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发表时间：
2013-11
影响因子：
4.3
通讯作者：
Goodsaid F
中科院分区：
文献类型：
--
作者：
Campion S;Aubrecht J;Boekelheide K;Brewster DW;Vaidya VS;Anderson L;Burt D;Dere E;Hwang K;Pacheco S;Saikumar J;Schomaker S;Sigman M;Goodsaid F
在药物开发中有很大的损耗率。由于在临床前研究和临床中准确监测毒性的工具有限，许多化合物未能在临床前开发中取得进展。研究的重点是通过鉴定和描述毒性生物标志物来改进检测器官特异性毒性的工具。本文回顾了我们所知道的毒理学中新兴的生物标志物，重点是2012年东北毒理学学会题为“毒理学中的转化生物标志物”的会议。总结了本次会议涵盖的领域，包括睾丸损伤和功能障碍的生物标志物，肾损伤的新兴生物标志物以及从临床前物种到人群的新兴生物标志物的翻译。作者还提供了关于生物标志物确认过程和该过程可能改进的讨论。目前，在开发和鉴定用于非临床药物安全性评估的新型生物标志物的科学工作与这些生物标志物如何实际用于药物安全性评估之间存在差距。需要一个明确而有效的监管接受途径，以便在非临床药物安全性评估的生物标志物工具包中取得突破，从而有助于药物开发过程。
There are significant rates of attrition in drug development. A number of compounds fail to progress past preclinical development due to limited tools that accurately monitor toxicity in preclinical studies and in the clinic. Research has focused on improving tools for the detection of organ-specific toxicity through the identification and characterization of biomarkers of toxicity. This article reviews what we know about emerging biomarkers in toxicology, with a focus on the 2012 Northeast Society of Toxicology meeting titled ‘Translational Biomarkers in Toxicology.’ The areas covered in this meeting are summarized and include biomarkers of testicular injury and dysfunction, emerging biomarkers of kidney injury and translation of emerging biomarkers from preclinical species to human populations. The authors also provide a discussion about the biomarker qualification process and possible improvements to this process. There is currently a gap between the scientific work in the development and qualification of novel biomarkers for nonclinical drug safety assessment and how these biomarkers are actually used in drug safety assessment. A clear and efficient path to regulatory acceptance is needed so that breakthroughs in the biomarker toolkit for nonclinical drug safety assessment can be utilized to aid in the drug development process.
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影响因子：
19.6
作者：
Bucaloiu, Ion D.;Kirchner, H. Lester;Perkins, Robert M.
通讯作者：
Perkins, Robert M.
影响因子：
6.7
作者：
Aston, Kenneth I.;Punj, Vasu;Carrell, Douglas T.
通讯作者：
Carrell, Douglas T.
影响因子：
4.5
作者：
Collings, Fitz B.;Vaidya, Vishal S.
通讯作者：
Vaidya, Vishal S.
影响因子：
5.2
作者：
Boissonnas, Celine Chalas;El Abdalaoui, Hafida;Jammes, Helene
通讯作者：
Jammes, Helene
影响因子：
4.9
作者：
Bonde, JP;Giwercman, A;Baranski, B
通讯作者：
Baranski, B