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

• Hoofdauteurs: Ji Yeon Kim (Auteur), Du Hyung Choi (Auteur)
• Formaat: Boek
• Gepubliceerd in: MDPI AG, 2022-11-01T00:00:00Z.
• Onderwerpen: article
• Online toegang: Connect to this object online.

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...