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Model Based Qbd in Drug Product

Wednesday, November 11, 2009: 3:15 PM
Hermitage C (Gaylord Opryland Hotel)

Description:
This session focuses on the use of mathematical models and simulation in establishing a Design Space in support of QbD for a Drug Product Operation. Authors are invited to share the challenges in the model development and validation, and the strategy used for QbD


Sponsor:
Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products
Co-Sponsor(s):
Systems and Process Design (10a), Process Development Division (12), Pharmaceuticals (15b)


Chair:
Fernando. J Muzzio
Email: fjmuzzio@yahoo.com

Co-Chair:
Nancy E. Sever
Email: nancy.sever@abbott.com


3:15 PM
(465a) Correlation of Material Properties and Process Parameters to Pharmaceutical Tablet Mechanical Characteristics Using a Quai-Continuum Model
Athanas A. Koynov and Alberto Cuitino

3:40 PM
(465b) Flowchart Methodology Utilizing Validated Process Models as the Foundation for a Quality-by-Design (QbD)-Based Approach for Pharmaceutical Unit Operations: Example Case Studies
Lisa J. Graham, Daniel E. Dobry and Ronald A. Beyerinck

4:05 PM
(465c) Model Based Approach to Determine Optimum Operating Conditions in High Shear Granulation
Defne Kayrak-Talay, James D. Litster and James K. Drennen III

4:30 PM
(465d) Modeling Density and Temperature Distributions in Powder Die Compacts
Jerry R. Klinzing, Antonios Zavaliangos, John Cunningham, Tracey Mascaro and Denita Winstead

4:55 PM
(465e) Film Coating End-Point Determination for Colored Immediate Release Tablets Using Multivariate Image Analysis
Salvador Garcia-Munoz and Daniel Gierer

5:20 PM
(465f) The Effect of Tablet Shape On Film Coating Uniformity Using the Discrete Element Method
William R. Ketterhagen
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture