An Optimization-Based Framework to Define the Probabilistic Design Space of Pharmaceutical Processes with Model Uncertainty

An Optimization-Based Framework to Define the Probabilistic Design Space of Pharmaceutical Processes with Model Uncertainty

To increase manufacturing flexibility and system understanding in pharmaceutical development, the FDA launched the quality by design (QbD) initiative. Within QbD, the <i>design space</i> is the multidimensional region (of the input variables and process parameters) where product quality...

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Bibliographic Details
Main Authors: Daniel Laky, Shu Xu, Jose S. Rodriguez, Shankar Vaidyaraman, Salvador García Muñoz, Carl Laird
Format: Article
Language:English
Published: MDPI AG 2019-02-01
Series:Processes
Subjects:
pharmaceutical processes
flexibility analysis
probabilistic design space
global optimization
Online Access:https://www.mdpi.com/2227-9717/7/2/96

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https://www.mdpi.com/2227-9717/7/2/96

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