Control Strategy for Excipient Variability in the Quality by Design Approach Using Statistical Analysis and Predictive Model: Effect of Microcrystalline Cellulose Variability on Design Space

Control Strategy for Excipient Variability in the Quality by Design Approach Using Statistical Analysis and Predictive Model: Effect of Microcrystalline Cellulose Variability on Design Space

Although various quality by design (QbD) approaches have been used to establish a design space to obtain robust drug formulation and process parameters, the effect of excipient variability on the design space and drug product quality is unclear. In this study, the effect of microcrystalline cellulos...

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Bibliographic Details
Main Authors: Ji Yeon Kim, Du Hyung Choi
Format: Article
Language:English
Published: MDPI AG 2022-11-01
Series:Pharmaceutics
Subjects:
microcrystalline cellulose
excipient variability
quality by design
design space
critical quality attributes
artificial neural networks
Online Access:https://www.mdpi.com/1999-4923/14/11/2416

Internet

https://www.mdpi.com/1999-4923/14/11/2416

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