藥物的安全性和有效性是藥物研發(fā)成功的決定因素，而藥物毒性是終止藥物研發(fā)的關(guān)鍵因素之一。相關(guān)監(jiān)管指南和指導(dǎo)原則為利用動(dòng)物進(jìn)行毒理學(xué)研究及生物測(cè)試或其他相關(guān)試驗(yàn)制定了基本標(biāo)準(zhǔn)。動(dòng)物體外替代試驗(yàn)不僅遵守了國(guó)際上提倡的“3R原則”，也符合毒理學(xué)學(xué)科發(fā)展、社會(huì)經(jīng)濟(jì)發(fā)展及新藥研發(fā)的要求。動(dòng)物體外替代試驗(yàn)已成為21世紀(jì)毒性測(cè)試的重要方向，毒性測(cè)試的重點(diǎn)將集中在敏感性終點(diǎn)的選擇與評(píng)價(jià)、細(xì)胞-反應(yīng)網(wǎng)絡(luò)、高通量與中通量篩選方法的構(gòu)建及應(yīng)用、作用機(jī)制及作用模式、毒性通路以及系統(tǒng)生物學(xué)效應(yīng)等方面，并且已獲得藥物研發(fā)領(lǐng)域廣泛的支持和監(jiān)管部門的認(rèn)可，具有廣闊的發(fā)展前景和重要的應(yīng)用價(jià)值。

The safety and efficacy of drugs are the determinants of the success of drug discovery and development, and drug toxicity is one of the key factors in stopping drug development. The relevant regulatory guidelines and principals establish basic standards for the use of animals for toxicological studies and biological tests or other related tests. In vitro alternative tests not only comply with the internationally promoted "3R Principles", but also the needs and scientific requirements for the development of toxicology disciplines, socio-economic development and the development of emerging therapeutic methods. In vitro animal alternative testing has become an important direction for toxicity testing in the 21st century. The focus of toxicity testing will focus on the selection and evaluation of sensitive endpoints, cell-response networks, the construction and application of high- and medium-throughput screening methods, mechanisms of action and modes of action, toxic pathways, and system biology effects, etc.. In vitro alternative test is being widely recognized and approved by the regulatory authorities, and has broad prospects for development and important application value.

“十二五”國(guó)家科技重大專項(xiàng)課題“符合中藥特點(diǎn)的有毒中藥安評(píng)關(guān)鍵技術(shù)”（2015ZX09501004-002）；“十二五”國(guó)家科技重大專項(xiàng)課題“生物大分子藥物特殊評(píng)價(jià)關(guān)鍵技術(shù)研究”（2015ZX09501007-004）