Model Based QbD In Drug Substance or Drug Product Development

Chair(s):
Marek, J., Abbott Laboratories
Co-chair(s):

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.

Papers:
12:30 PM
(701a) Modeling a Reactive Crystallization with a Reduced Population Balance Equation for Dissolution and Growth to Control Critical Quality Attributes
12:50 PM
(701b) Model-Based Characterisation of Organic and Aqueous Tablet Film Coating Processes: Parameter Estimation and Risk Management
1:10 PM
(701c) Design Space Verification for Tablet Dosage Form Using Modeling
1:30 PM
(701d) New Model-Based Platform for Enhanced Content Uniformity Prediction of Oral Dosage Forms
1:55 PM
(701e) Computation of Reliabilities for Extent of Reactant Conversion Incorporating Batch Effects with Applications to ICH Q8 Design Space
2:15 PM
(701f) Estimating Reaction Model Uncertainty with Bayesian Markov Chain Monte Carlo
2:35 PM
(701g) Controllability Analysis of Protein Glycosylation In CHO Cells

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Pricing

Individuals

2011 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