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新药和产品国际注册登记的稳定性试验准则美国食品药品管理局萧叁供稿）本文下列准则是在国际协调大会（ＩｎｔｅｒｎａｔｉｏｎａｌＣｏｎｆｅｒｅｎｃｅｏｎＨａｒｍｏｎｉｚａｔｉｏｎ）的质量专家工作组产生的。该工作组包罗了欧洲、日本和美国的管理当局和工业组织的...
Guidelines for the Stability Test of New International Registrations of New Drugs and Products (US Food and Drug Administration Xiao San) The following guidelines were produced by the Quality Experts Working Group at the International Conference on Harmonization. The working group includes the regulatory authorities and industrial organizations in Europe, Japan and the United States ...