application of quality by design in the current drug development

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ID: 224125
2017
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Abstract
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.
Reference Key
zhang2017asianapplication Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Lan Zhang;Shirui Mao
Journal topics in organometallic chemistry
Year 2017
DOI
10.1016/j.ajps.2016.07.006
URL
http://www.sciencedirect.com/science/article/pii/S1818087616300575
Keywords
risk assessment quality by design (qbd) pharmacology

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