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11 Empirical Modeling and Experimental QbD

Thursday, November 12, 2009: 3:15 PM
Bayou A (Gaylord Opryland Hotel)

Description:
QbD is typically addressed and implemented by using experimental design, statistics and empirical modeling. Talks are invited to share their experience in using DOE or alternate proposals to DOE, traditional statistics or multivariate latent variable methods in establishing a Design Space


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:
Mark-John Bruwer
Email: mj.bruwer@prosensus.ca

Co-Chair:
Chris McCready
Email: Chris.McCready@umetrics.com


3:15 PM
(593a) Improving Process Understanding through Good Experimental Planning
Kelly Canter and Leonard Perry

3:40 PM
(593b) The Use of the Design of Dynamic Experiments Methodology to Quantify the Design Space in QbD Tasks
Christos Georgakis

4:05 PM
(593c) The ICH Q8 Definition of Design Space: A Comparison of the Overlapping Means and the Bayesian Predictive Approaches
John J. Peterson and Kevin R. Lief

4:30 PM
(593d) Correlating Powder Flowability to Particle Size Distribution Using Chemometric Techniques
Christopher L. Burcham and Robert T. Roginski

4:55 PM
(593e) Predictive Modeling of Pharmaceutical Processes with Missing and Noisy Data
Fani Boukouvala, Fernando Muzzio and M.G. Ierapetritou

5:20 PM
(593f) Nonlinear Programming Based Methods for PCA Parameter Estimation Using Data with Missing Elements
Rodrigo López-Negrete de la Fuente, Salvador Garcia-Munoz and Lorenz T. Biegler
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture