Comprehensive Study of Intermediate and Critical Quality Attributes for Process Control of High-Shear Wet Granulation Using Multivariate Analysis and the Quality by Design Approach

Comprehensive Study of Intermediate and Critical Quality Attributes for Process Control of High-Shear Wet Granulation Using Multivariate Analysis and the Quality by Design Approach

A robust manufacturing process and the relationship between intermediate quality attributes (IQAs), critical quality attributes (CQAs), and critical process parameters (CPPs) for high-shear wet granulation was determined in this study. Based on quality by the design (QbD) approach, IQAs, CQAs, and C...

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Bibliographic Details
Main Authors: Jong Kwon Han, Beom Soo Shin, Du Hyung Choi
Format: Article
Language:English
Published: MDPI AG 2019-06-01
Series:Pharmaceutics
Subjects:
quality by design
scale-up strategy
critical process parameters
intermediate quality attributes
high-shear wet granulation
multivariate analysis
Online Access:https://www.mdpi.com/1999-4923/11/6/252

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