隨著現(xiàn)代分子生物學(xué)技術(shù)的快速發(fā)展，生物標(biāo)志物的研究成為臨床前藥物安全性評(píng)價(jià)中發(fā)展最快的領(lǐng)域。同時(shí)，生物標(biāo)志物的定義、可使用的驗(yàn)證以及廣泛使用的有關(guān)問題也逐漸受到關(guān)注。就臨床前藥物安全性評(píng)價(jià)中相關(guān)的生物標(biāo)志物驗(yàn)證的概念、藥品監(jiān)督管理部門對(duì)生物標(biāo)志物驗(yàn)證的要求、藥物臨床前安全性評(píng)價(jià)中已驗(yàn)證的生物標(biāo)志物、生物標(biāo)志物驗(yàn)證的過程以及未來面臨的問題等進(jìn)行簡(jiǎn)要的論述。

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.

國(guó)家科技重大專項(xiàng)資助項(xiàng)目（2015ZX09501007）