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Conference Presentations - 2010 AIChE Annual Meeting

Toward a More Reliable USP Dissolution Testing Apparatus II

Nov 7, 2010
Yimin Wang
In the pharmaceutical industry, dissolution testing is a critical step in quality control and a standard method for assessing batch-to-batch consistency of solid oral drug delivery systems, such as tablets. One of the most widely used dissolution test devices is the UPS Apparatus II (paddle). Even...

Design and Construction of a Protein Degradation Switch

Nov 7, 2010
S. Marjan Varedi K.
Targeted protein degradation in eukaryotic cells requires recruitment of the target protein to proteasome which is usually triggered by ubiquitination of the target protein. It has recently been shown that ubiquitination is not necessary and localization to the proteasome is sufficient for...

QbD for Generic Drugs: A Case Study for Immediate-Release Products

Nov 7, 2010
Zhigang Sun
Quality by design (QbD) is a systematic approach for product and process design and development to ensure predefined product quality. Although the recent ICH guidelines (Q8-Q10) have provided an outline for development of “high quality” pharmaceutical products based on a comprehensive QbD approach...

Quality by Design for Generic Drugs: Overview

Nov 7, 2010
Robert A. Lionberger
Quality by design is an essential part of the modern approach to pharmaceutical quality. But there is uncertainty in the generic drug industry about how the core concepts in ICH Q8(R1) will apply to development of generic drugs. FDA's Office of Generic Drugs has been revising its approaches to...

Fouling Monitoring Techniques for Water Treatment Membrane Processes

Nov 7, 2010
Kuo-Lun Tung
Membrane fouling and flux decline are undesirable, albeit inevitable, problems in membrane filtration processes for water treatment. The development of low fouling membranes, the design of high efficiency modules, the selection of optimal operational strategies, and several improvements made in...

Treatment of Produced Water Using Microbial Fuel Cells

Nov 7, 2010
Abhijeet P. Borole
Sustainable utilization of natural energy sources in the future will require development of technologies with minimal impact on the environment. Produced water generated from oil and gas production operations currently generate 10 times more water than the amount of fossil fuel produced. In order...

Quality by Design in Pharmaceutical Development

Nov 7, 2010
Yatindra Joshi
More than 70% of the prescriptions in the US are now filled with generic products, and therefore, the industry has the responsibility to continue to provide safe, effective, and affordable medications. In 2009 GPhA initiated a dialogue between the Industry and the US FDA Office of Generics on...

QbD in Generic Drug Development: PAT Application

Nov 7, 2010
Salah U. Ahmed, Yanming Zu
A generic drug product is pharmaceutically and therapeutically equivalent to a Reference Listed Drug (RLD) product. It meets the same requirements for identity, purity, quality, stability, and complies with the same rigid standards of GMP regulations for manufacturing as the innovator product. In...

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