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[摘要]
美国食品药品管理局(FDA)于2019年2月发布了"供企业用戒烟及相关适应症:开发尼古丁替代疗法药品的指导原则"(草案)。该指导原则介绍了FDA对尼古丁替代疗法(NRT)药品总体开发方案的建议,而我国目前尚无类似指导原则。介绍该指导原则的主要内容,期待对我国这类药的研发有益。
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[Abstract]
The FDA issued the Smoking Cessation and Related Indications:Developing Nicotine Replacement Therapy Drug Products Guidance for Industry (Draft) in February 2019. This guidance describes the FDA's recommendations regarding overall development programs to nicotine replacement therapy (NRT) drug products. There is no similar guidance in our country at present. This paper introduces the main contents of the guidance. It is expected to be beneficial to the research and development of this kind of drug products in China.
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