Application of quality by design in the current drug development

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• 作者：Lan Zhang ; Shirui Mao ; ^{maoshirui@syphu.edu.cn}
• 关键词：Quality by design (QbD) ; Process analytical technology (PAT) ; Critical quality attributes (CQA) ; Design of experiment (DoE) ; Risk assessment ; Near infrared (NIR) spectroscopy
• 刊名：Asian Journal of Pharmaceutical Sciences
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：12
• 期：1
• 页码：1-8
• 全文大小：802 K
• 卷排序：12

文摘

Quality by Test was the only way to guarantee quality of drug products before FDA launched current Good Manufacturing Practice. To clearly understand the manufacture processes, FDA generalized Quality by Design (QbD) in the field of pharmacy, which is based on the thorough understanding of how materials and process parameters affect the quality profile of final products. The application of QbD in drug formulation and process design is based on a good understanding of the sources of variability and the manufacture process. In this paper, the basic knowledge of QbD, the elements of QbD, steps and tools for QbD implementation in pharmaceutics field, including risk assessment, design of experiment, and process analytical technology (PAT), are introduced briefly. Moreover, the concrete applications of QbD in various pharmaceutical related unit operations are summarized and presented.