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wch7401

新虫 (初入文坛)


[求助] 药物运输过程中的稳定性试验设计

请教各位:我们有一个API,药典保存条件2-8度,现在出口到美国,需做一个运输过程中的稳定性实验,请教各位这样的稳定性方案应如何设计?
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dingjinglvde

木虫 (正式写手)

【答案】应助回帖

感谢参与,应助指数 +1
可参考Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, PDA Technical Report No.39, Revised 2007
2楼2012-05-04 11:17:40
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