药物In-use stability testing或称为使用中稳定性试验,通过模拟产品实际使用场景,对关键指标如物理、化学、微生物学/生物学等参数进行研究,证明随着时间的推移,在温度、空气、光照、湿度等环境因素影响下,关键指标符合既定质量标准,从而确定使用中存储条件、期限等,目的是为如多剂量药物开启后存储条件、使用期限,或临床...
··前言药物In-use stability testing或称为使用中稳定性试验,通过模拟产品实际使用场景,对关键指标如物理、化学、微生物学/生物学等参数进行研究,证明随着时间的推移,在温度、空气、光照、湿度等环境因素影响下,关键指标符合既定质量标准,从而确定使用中存储条件、...
In-use stability of the finished product 青云英语翻译 请在下面的文本框内输入文字,然后点击开始翻译按钮进行翻译,如果您看不到结果,请重新翻译! 翻译结果1翻译结果2翻译结果3翻译结果4翻译结果5 翻译结果1复制译文编辑译文朗读译文返回顶部 在使用中的稳定性的成品...
in use stability专题研究 In use stability专题研究 Zhulikou431 内部培训 2012 中国
网络使用稳定性 网络释义 1. 使用稳定性 石油英语词汇(S6)--石油百科 ... stability in storage 储存安定性stability in use使用稳定性stability index 稳定性指数 ... www.oilnews.com.cn|基于18个网页
[2].Blümel M, Liu J, de Jong I, Weiser S, Fast J, Litowski J, Shuman M, Mehta SB, Amery L, Tan DCT, Jia F, Shekhawat D, Dagallier C, Emamzadeh M, Medina A, Santos C, Gasser F, Urban C. Current Industry Best Practice on in-use Stability and Compatibility Studies for Biolo...
Experimental design and modeling of in-use stability testing are presented in this paper. In-use open container degradation is considered in terms of time open container or/and the number of instances that the same container is used. Degradation is estimated based on two models, the fixed and ...
Experimental design and modeling of in-use stability testing are presented in this paper. In-use open container degradation is considered in terms of time open container or/and the number of instances that the same container is used. Degradation is estimated based on two models, the fixed and ...
In-use stability Test schedules with C-phases interrupted by A-phases were worked out for four different products referring to the planned in-use stability. For each product the respective schedule had to include at least the longest in-use stability (product D) and additionally, might have inc...
The use of liquid chromatography for purity and stability testing of bulk and formulated Pharmaceuticals is reviewed with particular regard to method devel... MW Dong,PV Passalacqua,DR Choudhury - 《Journal of Liquid Chromatography》 被引量: 20发表: 1990年 ...