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Practical Applications of QbD for a Parenteral Drug Product

机译：QBD对肠胃外药品的实际应用

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This presentation addresses the application of Quality by Design principles to two common unit operations encquntered in the manufacture of parenteral products. Examples will be described for 1) the application of mixing models to facilitate the scaler up of the API dissolution step, and 2) an approach for establishing a sterilization design space based on chemical kinetics and sterilization theory.

机译：本演示文稿通过设计原则来解决质量的应用，以在制造肠胃外产品中的两个共同单位操作。将描述实施例1）混合模型的应用以促进API溶解步骤的缩放器，以及2）一种基于化学动力学和灭菌理论建立灭菌设计空间的方法。

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来源
《AIChE Annual Meeting》|2011年||共3页
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作者
Nancy J. Harper; Venkat Koganti; Gautam R. Ranade;
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原文格式 PDF
正文语种
中图分类 TS2-532;
关键词
application; Design principles; parenteral products;

机译：应用;设计原则;肠胃外产品;

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4. Practical Applications of QbD for a Parenteral Drug Product [C] . Nancy J. Harper, Venkat Koganti, Gautam R. Ranade AIChE annual meeting . 2011

机译：QbD在肠胃外药品中的实际应用
5. Controlling drug delivery for the application of extended or sustained-release drug products for parenteral administration. [D] . O'Neil, Jacklyn. 2010

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Practical Applications of QbD for a Parenteral Drug Product

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