Session: Model Based QbD in Drug Substance or Drug Product (2010 Annual Meeting)

Thursday, November 11, 2010: 3:15 PM

Grand Ballroom B (Salt Palace Convention Center)

Description:

This session invites presentations in which response models have been developed from measured data for operations in drug substance or drug product development. These models may result from statistical design of experiments, a mechanistic / first principles approach, or a combination of the two. Submissions that address model verification are particularly welcome, for example using separate model development and model verification data sets.

Sponsor:

Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Co-Sponsor(s):

Pharmaceuticals (15b)

Chair:

Richard Schild
Email: richard.schild@bms.com

Co-Chair:

Nandkishor K. Nere
Email: nandkishor.nere@abbott.com

- indicates paper has an Extended Abstract file available on CD.

3:15 PM

(697a) Computational Predictive Models Applied to Scale-up of Solid Oral Drug Products
Mary T. Am Ende, Rahul Bharadwaj, Pankaj Doshi, Salvador Garcia-Munoz, William R. Ketterhagen and Andrew Prpich

3:35 PM

(697b) Achieving QM Accuracy at a Fraction of Computational Cost: Lattice Energy Minimization of Organic Crystals Containing Highly Flexible Molecules
Andrei V. Kazantsev, Panagiotis Karamertzanis, Claire S. Adjiman and Constantinos C. Pantelides

3:55 PM

(697c) Applications of Model-Based Quality by Design for Reaction Engineering
Stephen A. Guzikowski, James S. Bergum, Michael P. Cassidy, Chiajen J. Lai, Dong Lin, Sunil S. Patel, Michael E. Randazzo, Thomas M. Razler, Emily A. Reiff, Victor W. Rosso, Jose Tabora, John E. Thornton and Xuejun Xu

4:15 PM

(697d) Mixture DOE and Design Space
Patrick J. Whitcomb and Mark J. Anderson

4:35 PM

Break

4:45 PM

(697e) A Framework for in-Silico Formulation Design and Optimization Using Multivariate Latent Variable Regression Methods
Salvador Garcia-Munoz and Mark Polizzi

5:05 PM

(697f) Modelling and Informatics Challenges IN Film-BASED Drug Formulations and Manufacture
Maria Elisa Luque, Bo Zhou, Rodolfo Pinal, G. V. Reklaitis and Venkat Venkatasubramanian

5:25 PM

(697g) Quality by Design Approach to Pharmacokinetic Modeling. A Case Study On Cyclosporin A
Eric Lueshen, Cierra Hall, Andrej Mošať and Andreas A. Linninger

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

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