Application of Advanced Simulation Tools for Establishing Process Design Spaces Within the Quality by Design Framework
Author:
Affiliation:
1. Research Center Pharmaceutical Engineering GmbH; Graz Austria
2. Institute for Process and Particle Engineering; Graz University of Technology; Graz Austria
Publisher
John Wiley & Sons, Inc.
Reference84 articles.
1. An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation;Adam;Eur. J. Pharm. Sci.,2011
2. A science and risk based proposal for understanding scale and equipment dependencies of small molecule drug substance manufacturing processes;Am Ende;J. Pharm. Innov.,2010
3. Hilden J Schrad M Sloan JT Kuehne-Willmore J Kramer T Model-based control of drug substance particle size to ensure drug product uniformity Salt Lake City, Utah 2010
4. Hou DS MacPhail N Smith EJ Ho J Cleary A Implementation of a normalization risk assessment tool to link design space inputs Salt Lake City, Utah 2010
5. Michaels JN Bonsignore H Hudson-Curtis BL Laurenz S Lin H Mathai T Pande G Sheth A Sprockel O Can a design space be built on material attributes alone? Salt Lake City, Utah 2010
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