Nov. 4, 2008
College of Pharmacy part of group that receives FDA contract
The University of Iowa College of Pharmacy is part of a national consortium that recently received a $1.2 million contract from the U.S. Food and Drug Administration to develop guidelines that will enhance the way pharmaceutical products are made.
The National Institute for Pharmaceutical Technology and Education (NIPTE), which represents 11 U.S. universities that are leaders in pharmaceutical science and engineering, received the contract to develop a "Quality by Design" initiative. NIPTE works with FDA and private industry to establish and promote best practices in drug development and manufacturing.
"This seed grant is a tremendous initial opportunity for Iowa researchers to join forces with the agency and other academic scientists to improve the quality and safety of drug products," said Lee Kirsch, Ph.D., UI associate professor of pharmaceutics. "The UI is providing leadership and expertise to the team focused on devising new drug product stability guidelines."
In recognizing the award, UI Interim Vice President for Research Jordan Cohen added, "This work, which includes an interface with the UI College of Engineering, is an excellent example of the interdisciplinary research culture at UI."
"This brings a greater degree of science into the development process; bringing in more front-end quality and less dependence on back-end inspections," said Prabir Basu, Ph.D., executive director of NIPTE. "The framework developed through this research will be tested on a specific drug product."
The results of this study will potentially serve as the basis for formulating science-based guidance documents that can be used by FDA to evaluate new and generic drug applications. By strengthening the science-based technology through the Quality by Design initiative, FDA looks to improve its regulation of new medical products by using the best management approaches, information technology, and systems and review processes.
This research will begin this year and is expected be ongoing through September 2010.
In addition to the UI, NIPTE members include Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Kansas, University of Kentucky, University of Maryland-Baltimore and the University of Minnesota.
STORY SOURCE: University of Iowa Health Science Relations, 5139 Westlawn, Iowa City, Iowa 52242-1178
MEDIA CONTACT: David Pedersen, 319-335-8032, firstname.lastname@example.org