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Publications
Proceedings
2011 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Scale-up of Pharmaceutical Manufacturing Processes: Toward a QbD Approach
2011 Annual Meeting
Session: Scale-up of Pharmaceutical Manufacturing Processes: Toward a QbD Approach
Chair
Wu, H.
, FDA
Presentations
03:15 PM
(754a) Application of a Joint Risk Assessment Platform to Identify Suitable Drug Substance and Drug Product Process Options
Brown, J.
,
Lyngberg, O.
,
Hobson, L.
,
Kiang, S.
03:35 PM
(754b) Improved Process Understanding Through Implementation of QbD Methodologies
Grosser, S. T.
,
Moment, A.
,
Spartalis, A.
,
Zhou, G.
,
Fernandez, P.
03:55 PM
(754c) Harnessing Computational Fluid Dynamics (CFD) to Guide Reliable Scale-up of Pharmaceutical Processes
Czyzewski, A. M.
,
Tung, H. H.
,
Bordawekar, S. V.
04:15 PM
(754d) Model-Guided Quality by Design: A Case Study On a Pharmaceutical Final Intermediate
Xu, Z.
,
Bergum, J. S.
,
Laporte, T. L.
,
Tabora, J. E.
,
Spangler, L. A.
04:45 PM
(754e) Incorporating Computational Fluid Dynamics Methods for Quality by Design Framework for Exploring Design Space of a Fermentor
Nallamothu, S.
,
Muralikrishnan, R.
05:05 PM
(754f) Scaling up Strategy for Continuous Powder Mixing Process
Gao, Y.
,
Muzzio, F. J.
05:25 PM
(754g) Modified Application of Johanson's Model towards Roller Compaction