May 2012 | AIChE

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May 2012

Model-Based Characterisation of Organic and Aqueous Tablet Film Coating Processes: Parameter Estimation and Risk Management

Conference Presentation
AIChE Annual Meeting
October 19, 2011
Tablet coating is an important processing step in the pharmaceutical industry in which tablets are coated with an aqueous or organic film coating for...

Transferring Monitoring Models Between Different Scales Through Multivariate Statistical Techniques

Conference Presentation
AIChE Annual Meeting
October 18, 2011
The challenge of transferring a process monitoring model across different scales is a different problem than the one addressed in previous studies...

QbD for Generic MR Drug Products

Conference Presentation
AIChE Annual Meeting
October 18, 2011
The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug products. This is based principally upon a regulatory...

Automation and Control of Drug-On-Demand Technology

Conference Presentation
AIChE Annual Meeting
October 16, 2011
After the implementation of initiatives such as PAT and QbD, there has been a drive towards efficient manufacturing in the pharmaceutical industry...

De-Risking Scale-up of a High Shear Wet Granulation Process Using Latent Variable Modeling and near Infrared Spectroscopy

Conference Presentation
AIChE Annual Meeting
October 18, 2011
In the development of wet granulated drug products, two primary sources of variance (disturbance) include the operational scale of the high shear wet...

Managing Uncertainty In Design Space

Conference Presentation
AIChE Annual Meeting
October 19, 2011
Design of experiments, followed by numeric and graphical optimization, is frequently used by engineers to optimize a process, and to define a design...

Implementation of QbD Paradigm In Sterile Dosage Form Packaging – Some Practical Considerations

Conference Presentation
AIChE Annual Meeting
October 16, 2011
Out of all the pharmaceutical dosage forms, the Quality Target Product Profile (QTPP) for the sterile dosage form is the strictest for obvious...

Optical Coherence Tomography: A New PAT-Tool for Fast and Non-Destructive Analysis of Tablet Coating Quality

Conference Presentation
AIChE Annual Meeting
October 18, 2011
Optical coherence tomography (OCT) is a non-invasive imaging technique allowing fast and high-quality cross-sectional imaging of semi-transparent and...

QbD - It's Not Just for Breakfast Anymore

Conference Presentation
AIChE Annual Meeting
October 16, 2011
We are approaching the ten-year mark for the Quality by Design initiative in the pharmaceutical industry. Much has been accomplished and demonstrated...

Quality by Design for Generic Drugs

Conference Presentation
AIChE Annual Meeting
October 17, 2011
To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed...

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