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
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