Model Based QbD in Drug Substance or Drug Product

Chair(s):
Schild, R., Bristol-Myers Squibb
Co-chair(s):
Nere, N. K., Abbott Laboratories

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.

Papers:
3:15 PM
(697a) Computational Predictive Models Applied to Scale-up of Solid Oral Drug Products
3:35 PM
(697b) Achieving QM Accuracy at a Fraction of Computational Cost: Lattice Energy Minimization of Organic Crystals Containing Highly Flexible Molecules
3:55 PM
(697c) Applications of Model-Based Quality by Design for Reaction Engineering
4:15 PM
(697d) Mixture DOE and Design Space
4:45 PM
(697e) A Framework for in-Silico Formulation Design and Optimization Using Multivariate Latent Variable Regression Methods
5:05 PM
(697f) Modelling and Informatics Challenges IN Film-BASED Drug Formulations and Manufacture
5:25 PM
(697g) Quality by Design Approach to Pharmacokinetic Modeling. A Case Study On Cyclosporin A

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Individuals

2010 Annual Meeting
AIChE Members $150.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $225.00
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only
AIChE Members $100.00
AIChE Food, Pharmaceutical & Bioengineering Division Members Free
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $150.00