Development of quality-by-design analyti
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Frederick G. Vogt; Alireza S. Kord
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Article
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2011
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John Wiley and Sons
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English
โ 460 KB
Quality-by-design (QbD) is a systematic approach to drug development, which begins with predefined objectives, and uses science and risk management approaches to gain product and process understanding and ultimately process control. The concept of QbD can be extended to analytical methods. QbD manda