Gundert-Remy Ursula, Dahl Svein G, Boobis Alan, Kremers Pierre, Kopp-Schneider Annette, Oberemm Axel, Renwick Andrew, Pelkonen Olavi
Federal Institute for Risk Assessment, P.O. Box 330013, 14191 Berlin, Germany.
Toxicol Lett. 2005 Apr 10;156(2):227-40. doi: 10.1016/j.toxlet.2004.11.016. Epub 2005 Jan 8.
In the past, the term biomarker has been used with several meanings when used in human and environmental toxicology as compared to pharmaceutical development. However, with the advent of molecular approaches and their application in the field of drug development and toxicology, the concept of biomarkers has to be newly defined. In the meeting, the experts found consent in defining the term and described the application of biomarkers in toxicology, drug development and clinical diagnostics. Molecular approaches to biomarker identification and selection lead to a large amount of data. Hence, the statistical analysis is challenging and special statistical problems have to be solved in biomarker characterization, of particular interest are attempts aiming at class discovery and prediction. Reliability and biological relevance are to be demonstrated for biomarkers of exposure and effect which is also true for biomarkers of susceptibility. It is envisaged that the application of biomarkers will expand from current use in pre-clinical toxicology to the risk characterization and risk assessment of chemicals and from early clinical phases of drug development to later phases and even into daily clinical use in diagnostics and disease classification.
过去，与药物研发相比，生物标志物这一术语在人类和环境毒理学中的使用具有多种含义。然而，随着分子方法的出现及其在药物研发和毒理学领域的应用，生物标志物的概念必须重新定义。在此次会议上，专家们就该术语的定义达成了共识，并描述了生物标志物在毒理学、药物研发和临床诊断中的应用。用于生物标志物识别和选择的分子方法产生了大量数据。因此，统计分析具有挑战性，在生物标志物表征中必须解决特殊的统计问题，特别值得关注的是旨在类别发现和预测的尝试。对于暴露和效应的生物标志物，以及易感性生物标志物，都需要证明其可靠性和生物学相关性。预计生物标志物的应用将从目前在临床前毒理学中的使用扩展到化学品的风险表征和风险评估，以及从药物研发的早期临床阶段扩展到后期阶段，甚至应用于日常临床诊断和疾病分类。
