随着现代分子生物学技术的快速发展，生物标志物的研究成为临床前药物安全性评价中发展最快的领域。同时，生物标志物的定义、可使用的验证以及广泛使用的有关问题也逐渐受到关注。就临床前药物安全性评价中相关的生物标志物验证的概念、药品监督管理部门对生物标志物验证的要求、药物临床前安全性评价中已验证的生物标志物、生物标志物验证的过程以及未来面临的问题等进行简要的论述。

With the rapid development of modern molecular biology technology, the biomarker has recently been the fastest developing field in preclinical drug safety evaluation. Simultaneously, some problems about the definition and validation of biomarker, recognition, and wide use are gradually being concerned. In this paper, the definition of biomarker validation in preclinical safety evaluation of drug, related guidelines and regulatory requirements, verified biomarkers in preclinical safety evaluation, process of biomarker validation, and problems faced in the future are discussed briefly.

国家科技重大专项资助项目（2015ZX09501007）