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A strategy for population pharmaceutical quality assessment based on quality by design

Yu Zhao Changqin Hu Shangchen Yao Lihui Yin Xiaomei Ling

药物分析学报（英文）2021，Vol.11Issue(5)：588-595,8.

A strategy for population pharmaceutical quality assessment based on quality by design

Yu Zhao ¹Changqin Hu ²Shangchen Yao ¹Lihui Yin ¹Xiaomei Ling¹

作者信息

1. NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,National Institutes for Food and Drug Control,Beijing,102629,China
2. Acedemy for Advanced Interdisciplinary Studies,Peking University,Beijing,100088,China
折叠

摘要

关键词

Population pharmaceutical quality/Quality by design(QbD)/Crucial evaluation attributes(CEAs)/Process indicators(PIs)/Improved statistical process control(SPC)/Risk assessment

Key words

Population pharmaceutical quality/Quality by design(QbD)/Crucial evaluation attributes(CEAs)/Process indicators(PIs)/Improved statistical process control(SPC)/Risk assessment

引用本文复制引用

Yu Zhao,Changqin Hu,Shangchen Yao,Lihui Yin,Xiaomei Ling..A strategy for population pharmaceutical quality assessment based on quality by design[J].药物分析学报（英文）,2021,11(5):588-595,8.

基金项目

The National Major Scientific and Technological Special Project for ‘Significant New Drugs Development’(Grant No.:2017ZX0901001-007)provides support for this study. （Grant No.:2017ZX0901001-007）

药物分析学报（英文）

OASCI

ISSN：2095-1779

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