May 2012 | AIChE

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May 2012

Linkage of Critical Quality Attributes Across a Multi-Unit Operation Process Train Using a High-Shear Wet Granulation Design of Experiment

Conference Presentation
AIChE Annual Meeting
October 16, 2011
As the momentum for implementation of Quality by Design progresses in the pharmaceutical industry, more tools are being implemented to create better...

Design Space Definition Using a Variational Bayes' Approximation

Conference Presentation
AIChE Annual Meeting
October 19, 2011
The design space may be interpreted as the constrained region of the key manufacturing parameters space which provides assurance of quality of a drug...

Rational Design and Scale-up of Batch Lubrication Processes for Immediate Release Formulations

Conference Presentation
AIChE Annual Meeting
October 16, 2011
Purpose: To provide stepwise guidance for lubrication of pharmaceutical powders through the development of a unifying model which captures...

Dissolution Testing of Prednisone and Salicylic Acid Calibrator Tablets At Different Tablet Locations

Conference Presentation
AIChE Annual Meeting
October 19, 2011
Dissolution testing is routinely carried out in the pharmaceutical industry to determine the rate of dissolution of solid dosage forms. This test is...

Understanding the Impact of the Properties of Raw Materials Onto Product Quality Using JR-PLS

Conference Presentation
AIChE Annual Meeting
October 18, 2011
Multiple proposals are found in literature to analyze the impact of raw materials onto product using data analysis. From the methods proposed, the L-...

Mechanistic Investigation of Drug Release From Asymmetric Membrane Tablets

Conference Presentation
AIChE Annual Meeting
October 18, 2011
An asymmetric membrane (AM) tablet was developed for a soluble model compound to study the in vitro drug release mechanisms in challenge conditions,...

FDA Perspective On QbD for Analytical Methods

Conference Presentation
AIChE Annual Meeting
October 17, 2011
QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement. QbD provides new opportunities and modern tools to...

A Data-Driven Modeling Approach Using the Design of Dynamic Experiments Methodology In Calculating the Design Space of Batch Pharmaceutical Processes

Conference Presentation
AIChE Annual Meeting
October 19, 2011
The development of fundamental models for fed-batch pharmaceutical processes range from very challenging to almost impossible as not all the inner...

Mechanistic Models and Computer Software for Quality by Design In Formulation of Modified Release Dosage Forms

Conference Presentation
AIChE Annual Meeting
October 18, 2011
Modified release dosage forms (MRDFs) can be designed and manufactured in various shapes and structures using different materials. Depending on the...

PAT Application and Validation of Online Particle Sizing Measurement for Controlling a Critical Quality Attribute

Conference Presentation
AIChE Annual Meeting
October 18, 2011
In accordance with ICH Q8/9/10 and the FDA QbD initiative, companies are adding more and more PAT equipment, installing more sophisticated control...

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