Session: 11 Empirical Modeling and Experimental QbD (2009 Annual Meeting)

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
Chief Technology Officer
ProSensus Inc.
McMaster Innovation Park
Hamilton, ON L8S 4L7
Phone Number: 1-905-528-9136
Email: mj.bruwer@prosensus.ca

Co-Chair:

Chris McCready

Papers:

593a

Improving Process Understanding through Good Experimental Planning
Kelly Canter, Pfizer Inc.; Leonard Perry, University of San Diego

593b

The Use of the Design of Dynamic Experiments Methodology to Quantify the Design Space in QbD Tasks
Christos Georgakis, Tufts University

593c

The ICH Q8 Definition of Design Space: A Comparison of the Overlapping Means and the Bayesian Predictive Approaches
John J. Peterson, GlaxoSmithKline; Kevin R. Lief, GlaxoSmithKline

593d

Correlating Powder Flowability to Particle Size Distribution Using Chemometric Techniques
Christopher L. Burcham, Eli Lilly and Company; Robert T. Roginski, Eigenvector Research, Inc.

593e

Predictive Modeling of Pharmaceutical Processes with Missing and Noisy Data
Fani Boukouvala, Rutgers University; Fernando Muzzio, Rutgers University; M.G. Ierapetritou, Rutgers University, the State University of New Jersey

593f

Nonlinear Programming Based Methods for PCA Parameter Estimation Using Data with Missing Elements
Rodrigo López-Negrete de la Fuente, Carnegie Mellon University; Salvador Garcia-Munoz, Pfizer Global Research & Development; Lorenz T. Biegler, Carnegie Mellon University

See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

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