Quality by design- newer technique for pharmaceutical product development

Anwar Khan, Kamran Javed Naquvi,Md Faheem Haider, Mohsin Ali Khan

Intelligent Pharmacy(2023)

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摘要
Regulatory bodies are nowadays concerned with pharmaceutical drug products' safety, efficacy, and quality. Quality is the priority of all regulatory bodies, it is a high priority for the triple P factor (patient, pharmacist, and physician). It links pharmaceutical industries and regulatory authorities for designing, manufacturing, and consistently delivering safe and efficient products.
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关键词
Quality by design (QbD),Quality target product profile (QTPP),Critical quality attribute (CQA),Design of experiment (DOE),Process analytical technique (PAT),Design space,Control space
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