Role of Automatic Process Control in Quality by Design

Mo Jiang,Nicholas C. S. Kee,Xing Yi Woo,Li May Goh,Joshua D. Tice,Lifang Zhou,Reginald B. H. Tan,Charles F. Zukoski,Mitsuko Fujiwara,Zoltan K. Nagy,Paul J. A. Kenis,Richard D. Braatz

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture（2017）

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摘要

The US Food and Drug Administration defines Quality by Design (QbD) as “a systematic approach to pharmaceutical development that begins with pre defined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”[1]. Pharmaceutical development includes the following elements [2]:

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