Aspects and Implementation of Pharmaceutical Quality by Design from Conceptual Frameworks to Industrial Applications

Aspects and Implementation of Pharmaceutical Quality by Design from Conceptual Frameworks to Industrial Applications

<b>Background/Objectives:</b> Quality by Design (QbD) has revolutionized pharmaceutical development by transitioning from reactive quality testing to proactive, science-driven methodologies. Rooted in ICH Q8–Q11 guidelines, QbD emphasizes defining Critical Quality Attributes (CQAs), esta...

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Bibliographic Details
Main Authors: Shiwei Yang, Xingming Hu, Jinmiao Zhu, Bin Zheng, Wenjie Bi, Xiaohong Wang, Jialing Wu, Zimeng Mi, Yifei Wu
Format: Article
Language:English
Published: MDPI AG 2025-05-01
Series:Pharmaceutics
Subjects:
quality by design
design of experiments
drug development
Online Access:https://www.mdpi.com/1999-4923/17/5/623
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