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

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
Principal Scientist
Bristol-Myers Squibb Company
Process Research and Development
One Squibb Drive
New Brunswick, NJ 08903
Phone Number: 732-227-7960
Fax Number: 732-227-3940
Email: richard.schild@bms.com

Co-Chair:

Nandkishor K. Nere
Senior Scientist II Engineering
Abbott Laboratories
Process R&D, Global Pharmaceutical Reseach and Development
1401 Sheridan Rd.
North Chicago, IL 60064
Phone Number: 847-937-5511
Email: nandkishor.nere@abbott.com

Papers:

697a

Computational Predictive Models Applied to Scale-up of Solid Oral Drug Products
Mary T. Am Ende, Pfizer Global Research & Development; Rahul Bharadwaj, Pfizer Global Research & Development; Pankaj Doshi, National Chemical Laboratory; Salvador Garcia-Munoz, Pfizer Global Research & Development; William R. Ketterhagen, Pfizer Global Research & Development; Andrew Prpich, Pfizer Global Research & Development

697b

Achieving QM Accuracy at a Fraction of Computational Cost: Lattice Energy Minimization of Organic Crystals Containing Highly Flexible Molecules
Andrei V. Kazantsev, Imperial College London; Panagiotis Karamertzanis, Imperial College London; Claire S. Adjiman, Imperial College London; Constantinos C. Pantelides, Process Systems Enterprise Ltd.

697c

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

697d

Mixture DOE and Design Space
Patrick J. Whitcomb, Stat-Ease, Inc.; Mark J. Anderson, Stat-Ease, Inc.

Break

697e

A Framework for in-Silico Formulation Design and Optimization Using Multivariate Latent Variable Regression Methods
Salvador Garcia-Munoz, Pfizer Global Research & Development; Mark Polizzi, Pfizer Global Research & Development

697f

Modelling and Informatics Challenges IN Film-BASED Drug Formulations and Manufacture
Maria Elisa Luque, Purdue University; Bo Zhou, Purdue University; Rodolfo Pinal, Purdue University; G. V. Reklaitis, Purdue University; Venkat Venkatasubramanian, Purdue University

697g

Quality by Design Approach to Pharmacokinetic Modeling. A Case Study On Cyclosporin A
Eric Lueshen, University of Illinois at Chicago; Cierra Hall, University of Illinois at Chicago; Andrej Mošať, University of Illinois at Chicago; Andreas A. Linninger, University of Illinois at Chicago

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

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