摘 要：創(chuàng)新藥物研究和開發(fā)的理論、方法和關(guān)鍵技術(shù)隨著生物技術(shù)的發(fā)展而發(fā)展，我國(guó)創(chuàng)新藥物研究獲得前所未有的機(jī)遇，也面臨著重大挑戰(zhàn)。在“關(guān)鍵路徑研究”中，實(shí)施轉(zhuǎn)換醫(yī)學(xué)研究或轉(zhuǎn)換研究不但影響醫(yī)藥企業(yè)的新產(chǎn)品研發(fā)過程，也會(huì)對(duì)研發(fā)機(jī)制產(chǎn)生深遠(yuǎn)的影響。轉(zhuǎn)換醫(yī)學(xué)為提高研究開發(fā)效率提供了機(jī)遇和挑戰(zhàn)，在新藥發(fā)現(xiàn)、研究開發(fā)、臨床前和臨床評(píng)價(jià)研究的各個(gè)階段，應(yīng)用轉(zhuǎn)換研究模式，科學(xué)地利用獲得的有用信息，把握轉(zhuǎn)換研究與新藥研發(fā)三要素，定能降低研發(fā)成本和縮短研究時(shí)間，提高研發(fā)效率和速度。筆者主要論述轉(zhuǎn)換醫(yī)學(xué)的發(fā)展、國(guó)際動(dòng)態(tài)、我國(guó)創(chuàng)新藥物研究所面臨的機(jī)遇和挑戰(zhàn)等方面的內(nèi)容。

Abstract：Current innovative drug research and development of the theory，methods，and key technology is the rapid emergence of China will be conducive to the research of innovative medicines to improve the strength and the overall level．For the establishment of China's independent innovation system，so we face major challenges in innovative drug research in China to reach close to the country's overall level．Translational medicines proves the opportunities and challenges in drug discovery，research and development（R&D），preclinical and clinical evaluation of the various stages of conversion of application mode，use the three elements of druggablity to evaluate of new drugs. This review will convert the development of translational medicine，the international statues，and the opportunities and challenges in application to R&D of new drugs．