Working within the Design Space: Do Our Static Process Characterization Methods Suffice?

Working within the Design Space: Do Our Static Process Characterization Methods Suffice?

The Process Analytical Technology initiative and Quality by Design paradigm have led to changes in the guidelines and views of how to develop drug manufacturing processes. On this occasion the concept of the design space, which describes the impact of process parameters and material attributes on th...

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Bibliographic Details
Main Authors: Moritz von Stosch, René Schenkendorf, Geoffroy Geldhof, Christos Varsakelis, Marco Mariti, Sandrine Dessoy, Annick Vandercammen, Alexander Pysik, Matthew Sanders
Format: Article
Language:English
Published: MDPI AG 2020-06-01
Series:Pharmaceutics
Subjects:
process analytical technology
quality by design
dynamic design space
reachability
flexibility
dynamic modeling
Online Access:https://www.mdpi.com/1999-4923/12/6/562

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