目的 综述新分子实体（new molecular entity，NME）这一概念的准确含义及其与新药研发的关系。方法 查阅美国食品药品监督管理局（FDA）网站资料和相关文献，对新分子实体的含义进行分析、推理和总结。结果 新分子实体与化合物是否已知、药物治疗效果以及药物的质量水平没有关系；新分子实体的开发遵从药物研究的一般要求，虽然开发难度大，但具有一定潜在优势。结论 准确理解新分子实体的含义能够有效避免新药研发中由于概念不清带来的弊端，更好地促进新药研发。
关键词
新分子实体 /
新药研发 /
化合物
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参考文献
[1] FDA US. FOOD AND DRUG ADMINISTRATION. Drugs@FDA Glossary of Terms [EB/OL]. Drug Approvals and Databases， 2010 [2011-10-22]. http：//www. fda. gov/Drugs/InformationOnDrugs/ucm079436. htm#N.
[2] MULLARD A. 2010 FDA drug approvals [J]. Nat Rev Drug Discov， 2011， 10(2) ：82-85.
[3] TANG Z M. Introduction and analysis to the U S. FDA’s new drug approvals in 2010 [J]. J Int Pharm Res (国际药学研究杂志)， 2011， 38(1) ：71-85.
[4] EUROPEAN COMMISSION. Opinion on polidocanol (Laureth-9) [EB/OL]. Scientific Committee， 2007 [2011-10-22]. http：//ec. europa. eu/health/ph_risk/committees/04_sccp/docs/sccp_o_113. pdf.
[5] ECKMANN D M. Polidocanol for endovenous microfoam sclerosant therapy [J]. Expert Opin Investig Drugs， 2009， 18(12) ：1919-1927.
[6] SHERRATT R M， BOSTOCK H， SEARS T A. Effects of 4-aminopyridine on normal and demyelinated mammalian nerve fibres [J]. Nature， 1980， 283(5747) ：570-572.
[7] DU G H， LV Y. The study of drug quantity and the control of drugs effects [J]. Food and Drug (食品与药品)， 2008， 10(5) ：1-4.
[8] FOOD AND DRUG ADMINISTRATION. The future of drug safety-promoting and protecting the health of the public [EB/OL]. FDA’s Response to the Institute of Medicine’s 2006 Report， 2007 [2011-10-22]. http：//www. fda. gov/downloads/Drugs/Drug Safety/Postmarket Drug SafetyInformationfor Patientsand Providers/UCM171627. pdf.
[9] DEPUTY OFFICE DIRECTOR FOR SCIENCE OFFICE OF CLINICAL PHARMACOLOGY & BIOPHARMACEUTICS CDER， FDA. Pharmacogenetics-Pharmacogenomics in early drug development： regulatory expectations. AAPS Annual Meeting， 2006 [2011-10-22]. http：//www. fda. gov/downloads/ Drugs/ScienceResearch/ResearchAreas/ Pharmacogenetics/ucm085604. pdf.
[10] DIMASI J A， FELDMAN L， SECKLER A， et al. Trends in risks associated with new drug development： success rates for investigational drugs [J]. Clin Pharmacol Ther， 2010， 87(3)：272-277.
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