近年來藥物不良反應(yīng)引起全球的關(guān)注.伴隨著藥物基因組學(xué)的發(fā)展,為了提高用藥的精準(zhǔn)性和有效性,2013年10月美國食品與藥品監(jiān)督管理局(FDA)發(fā)布了"為個(gè)體化用藥鋪平道路—FDA在醫(yī)療產(chǎn)品發(fā)展新時(shí)代中的作用"的報(bào)告.在解讀該報(bào)告基礎(chǔ)上,從個(gè)體化用藥的定義以及實(shí)現(xiàn)條件兩方面闡釋了個(gè)體化用藥的新內(nèi)涵,并簡要分析了個(gè)體化用藥新時(shí)代背景下的新藥研究和應(yīng)用概況,以及所面臨的機(jī)遇和挑戰(zhàn).同時(shí)對我國個(gè)體化用藥的發(fā)展現(xiàn)狀和亟待解決的問題進(jìn)行分析,旨在為我國的新藥研發(fā)以及個(gè)體化給藥的順利推進(jìn)提供借鑒和參考.

Inrecent years, drug adverse reaction (ADR) has been paid more attention all over the world. With the aim of improving drug effectiveness and accuracy, the US Food and Drug Administration (FDA) issueda report titled "Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development" in October 2013. On the basis of thoroughly interpretation of the report, new connotation of personalized medicine was elucidated from both its definition and conditions realized, and current status of drug development as well asopportunities and challenges we face under the new era of personalized medicine were briefly analyzed. In the meantime, current status and problemsto be solved in China were also analyzed to provide the reference for new drug development and personalized medicine in the future.