节点文献
欧美非处方药药品说明书可读性测试简介及启示
Brief Introduction and Implication of the Package Leaflet Readability Guidelines of FDA and EMA
【摘要】 目的对欧美非处方药(OTC)药品说明书可读性指南进行介绍,以期对我国OTC药品说明书可读性研究提供借鉴。方法通过查阅国外文献,应用文献研究的方法进行分析对比。结果欧美开展药品说明书可读性测试后的说明书内容和效果与我国有较大差异。结论我国应借鉴欧美OTC药品说明书可读性研究的相关内容,提高我国OTC药品说明书的可读性。
【Abstract】 Objective To introduce the readability guidelines of package leaflet in FDA and EMA,and put forward suggestions on developing labelling readability of China.Methods Literature study were used to analyze the foreign materials,and contrast the differences between China and them.Results There is a big difference between foreign countries and China on labelling content and effect after readability tests of package leaflet.Conclusions We should learn achievement from FDA and EMA to improve readability of labelling.
- 【文献出处】 中国药物警戒 ,Chinese Journal of Pharmacovigilance , 编辑部邮箱 ,2013年08期
- 【分类号】R951
- 【被引频次】9
- 【下载频次】316