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Publications
Proceedings
2011 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Application of Quality by Design In API Process Development
2011 Annual Meeting
Session: Application of Quality by Design In API Process Development
Co-Chair
Sanjeev Katti
, Genzyme Corporation
Presentations
08:30 AM
(202a) Application of Design Space Mapping Accounting for Model Uncertainty and Common Cause Variability In Drug Substance Development
Shankar Vaidyaraman, Isabel Figueroa, Sze Wing Wong
08:55 AM
(202b) Design Space Development for the Final Recrystallization Process for Axitinib, a Complex Solvating API
Steven M. Guinness
09:20 AM
(202c) Impurity Fate Mapping In the Development of Pazopanib
Michael A. McGuire
09:45 AM
(202d) A Model-Centric Solution to Link Content Uniformity Targets with API Particle Size Specifications and Process for a QbD Excercise
Mark A. Pinto, Salvador García-Muñoz, Weili Yu, Sean K. Bermingham
10:10 AM
(202e) Process QbD Case Study: An Integrated PAT Approach for a Dynamic Pharmaceutical Co-Precipitation Process Characterization and Process Design Space Development
Huiquan Wu, Mansoor A Khan
10:35 AM
(202f) A QbD Approach to Improve Tablet Coating Uniformity
Atul Dubey, Golshid Keyvan, Fani Boukouvala, Richard Hsia, Kostas Saranteas, Dean Brone, Tushar Misra, Fernando J. Muzzio
