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huanwon

铁虫 (小有名气)

[求助] 药用辅料相关的法规、标准、指导原则有哪些? 已有1人参与

请问与药用辅料相关的法规、标准、指导原则,除了《药用辅料生产质量管理规范》、《药用辅料注册申报资料要求》、《药典》之外,还有哪些?
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wangyc3

至尊木虫 (著名写手)

新药研发

【答案】应助回帖

感谢参与,应助指数 +1
最好还是到SFDA网站上自己看,比较全面,国内的,FDA的指导原则。FDA不是有个辅料用量数据库么,挺好的。制剂人一般还是看辅料书籍多一些
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2楼2014-02-25 21:37:36
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