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A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.
FDA has awarded Long Island University’s (LIU’s) Arnold and Marie Schwartz College of Pharmacy and Health Sciences (LIU Pharmacy) a $2-million grant for a research initiative titled “Building towards Statistically-Based Pharmaceutical Quality Standards.” The grant will be awarded over three years, and will be used to study variability in marketed pharmaceutical product.
LIU’s research will focus on assessing variability in some key non-clinical performance properties of a range of products. These properties, such as the rate at which tablets dissolve, are key to ensuring that products can be manufactured so that their quality and performance is consistently good.
The grant will be shared with subcontractors at the Purdue University School of Chemical Engineering, where advanced statistical analysis will be used to jointly design and guide LIU’s experiments on how products perform in the laboratory. The findings will be used to generate statistical models to help better understand the design and manufacturing control needed for new drug products.
“The research conducted with this grant will lead to more effective drugs for patients around the world,” said LIU professor Dr. John Pezzuto, a past recipient of the American Association of Colleges of Pharmacy’s prestigious Volwiler Research Award. LIU Pharmacy is home to the Lachman Institute for Pharmaceutical Analysis, the Joan B. and Samuel J. Williamson Institute for Pharmacometrics, and the Natoli Engineering Institute for Industrial Pharmacy Development and Research. It is also a member of the National Institute for Pharmaceutical Technology and Education, joining 15 other schools of pharmacy from across the United States to improve human health by advancing quality, safety, affordability and speed to market of medicines through collaborative research. It was founded in 1886 and was New York’s first college of pharmacy.