粉末综合性质表征在质量源于设计(QbD)中的应用附视频

被引:1
作者
王磊 [1 ]
陈芳晓 [1 ]
曾环想 [1 ]
赵万利 [1 ]
傅晓伟 [2 ]
机构
[1] 深圳致君制药有限公司
[2] Freeman Technology
关键词
质量源于设计; 气流分装; 流动性; 粉针制剂;
D O I
暂无
中图分类号
TQ460.6 [制药工艺];
学科分类号
100705 [微生物与生化药学];
摘要
通过研究粉针制剂的气流分装过程,探讨如何建立固体粉末的粉体学性质和粉针制剂产品分装质量的定量关系,以确定影响气流分装的关键因素,并通过质量源于设计的理念解决实际生产中的问题。
引用
收藏
页码:1086 / 1089
页数:4
相关论文
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[2]
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[3]
Pharmaceutical Quality by Design: Product and Process Development; Understanding; and Control[J] Lawrence X. Yu Pharmaceutical Research 2008,
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