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