2011 Annual Meeting

Session: Model Based QbD In Drug Substance or Drug Product Development

Chair

James Marek, Abbott Laboratories

Co-Chair

Presentations

12:30 PM

(701a) Modeling a Reactive Crystallization with a Reduced Population Balance Equation for Dissolution and Growth to Control Critical Quality Attributes
Daniel Patience, Linli He, Dale Mowrey, Partha Mudipalli, Michael Christie, Roger Bakale

12:50 PM

(701b) Model-Based Characterisation of Organic and Aqueous Tablet Film Coating Processes: Parameter Estimation and Risk Management
Salvador García Muñoz, Mark A. Pinto, Sean K. Bermingham

01:10 PM

(701c) Design Space Verification for Tablet Dosage Form Using Modeling
Penelope Butterell, Alex Chueh, Thomas P. Garcia, Kim Vukovinsky, Bernd Schuemmelfeder, Vincent E. McCurdy, Daniel Gierer

01:30 PM

(701d) New Model-Based Platform for Enhanced Content Uniformity Prediction of Oral Dosage Forms
Salvador García-Muñoz, Weili Yu

01:55 PM

(701e) Computation of Reliabilities for Extent of Reactant Conversion Incorporating Batch Effects with Applications to ICH Q8 Design Space
Rick Lewis, Zifang Guo, John Peterson

02:15 PM

(701f) Estimating Reaction Model Uncertainty with Bayesian Markov Chain Monte Carlo
Jacob Albrecht

02:35 PM

(701g) Controllability Analysis of Protein Glycosylation In CHO Cells
Melissa M. St. Amand, Kevin Tran, Anne S. Robinson, Babatunde A. Ogunnaike