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Publications
Proceedings
2012 AIChE Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Application of Quality by Design in API Process Development
2012 AIChE Annual Meeting
Session: Application of Quality by Design in API Process Development
Presentations
12:30 PM
Welcoming Remarks
12:35 PM
(466a) Application of Quality by Design Principles for An Existing Product for the Control of the Dimer Impurity in the Manufacturing Process
Gautam Samanta, Praveen K Sharma, S Srividhya, Kamlesh Pai Fondekar, K R Janardan Sarma, Saurabh Gupta, Grb Ravish, Y Raghuram
12:55 PM
(466b) Investigation of the Impact of Mode of Operation (Batch vs Flow) On Design Space Map
Sze Wing Wong
01:15 PM
(466c) A QbD Approach to the Process Development of Tofacitinib
Bob Dugger
01:40 PM
(466d) Design of a Pharmaceutical Manufacturing Process Using QbD Principles: The Challenge of Technical Transfer to Manufacturing and Lifecycle Development
Conor Collins, Steve Ball
02:00 PM
(466e) Strategy and Process for Effective Scale-up On the Removal of Pd During the Synthesis of A Drug Substance
Alexander Chu-Kung, Hsien-Hsin Tung
02:20 PM
(466f) Implementation of Reaction Modeling and Process Analytical Technology in Design Space Development
Michael Fenster, Antonio Ramirez, Robert Wethman
02:40 PM
(466g) Application of Quality by Design in API Process Development
Nirav Shah, Conny Vikstrom, Erik Johansson
03:00 PM
Concluding Remarks
