Start | Grid View | Browse by Day OR Group/Topical | Author Index | Keyword Index | Personal Scheduler

Model Based QbD In Drug Substance or Drug Product Development

Thursday, October 20, 2011: 12:30 PM
Symphony III (Hilton Minneapolis)

Description:
Understanding the relationships between the manufacturing process and product quality attributes is essential to implementing Quality-by-Design (Qbd), leading to robust processes and improved performance through operation in an appropriate design space. Speakers are invited to present models based on first-principles, statistical (including multivariate), or semi-empirical methods, and their use to develop design spaces during API process and drug product development. Submissions that address model verification or application at scale are particularly welcome.


Sponsor:
Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsor(s):
Pharmaceuticals (15b)


Chair:
James Marek
Email: james.marek@abbott.com

Co-Chair:
Robert E. Yule
Email: robert.e.yule@gsk.com



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 and 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, Mary T. Am Ende, Mark A. Pinto and Sean K. Bermingham


1:10 PM
(701c) Design Space Verification for Tablet Dosage Form Using Modeling
Mary T. am Ende, Thomas P. Garcia, Kim Vukovinsky, Penelope Butterell, Alex Chueh, Bernd Schuemmelfeder, Vincent E. McCurdy and Daniel Gierer


1:30 PM
(701d) New Model-Based Platform for Enhanced Content Uniformity Prediction of Oral Dosage Forms
Salvador García-Muñoz and Weili Yu


1:50 PM
Break


1:55 PM
(701e) Computation of Reliabilities for Extent of Reactant Conversion Incorporating Batch Effects with Applications to ICH Q8 Design Space
Brian R. Crump, Rick Lewis, Zifang Guo and John Peterson


2:15 PM
(701f) Estimating Reaction Model Uncertainty with Bayesian Markov Chain Monte Carlo
Jacob Albrecht


2:35 PM
(701g) Controllability Analysis of Protein Glycosylation In CHO Cells
Melissa M. St. Amand, Kevin Tran, Devesh Radhakrishnan, Anne S. Robinson and Babatunde A. Ogunnaike
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
<< Previous Session | Next Session >>