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Pharmacy Faculty, Students Lead Major FDA Product Development Project

Faculty and students from the School of Pharmacy continue to collaborate on a project aimed to improve the quality and safety of certain medications.

The National Institute for Pharmaceutical Technology and Education (NIPTE), a nonprofit organization dedicated to fundamental research and education in pharmaceutical product development and manufacturing, recently awarded Duquesne $237,000 for its ongoing research on behalf of the U.S. Food and Drug Administration (FDA).

Dr. Carl Anderson, director of the School of Pharmacy's Center for Pharmaceutical Technology, and Dr. James Drennen, associate dean for research and graduate programs, are leading the research project A QbD Approach to Process Development. Its goal is to enhance the industry's product development practice, thereby improving the efficiency of pharmaceutical manufacturing as well as the quality of drug products sold around the world.

"When complete, our work hopefully will serve as a practical example to the FDA and likely aid the agency in development of new policy," said Drennen.

This research will demonstrate the use of quality-by-design methods for effective medication production during a complex, multistep manufacturing process. A yet-to-be-named pharmaceutical manufacturing company will join the project by providing production scale manufacturing.

This project started at Duquesne in 2015, and this year's funding brings the total award from NIPTE to $474,000 to date.

Dr. Ira Buckner and Dr. Peter Wildfong, both associate professors of pharmaceutics at Duquesne, and a number of senior graduate students are assisting in the project. Additional faculty, students and post-doctoral scientists from the University of Connecticut and Purdue University are providing expertise in specific operations of the manufacturing process.

References:
Duquesne University Times

Duquesne University

Founded in 1878, Duquesne is consistently ranked among the nation's top Catholic universities for its award-winning faculty and tradition of academic excellence. Duquesne, a campus of nearly 9,500 graduate and undergraduate students, has been nationally recognized for its academic programs, community service and commitment to sustainability. Follow Duquesne University on Facebook, Twitter and Instagram.
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