community impact
UHSP Pharmaceutical and Administrative Sciences Chair Receives $1.2 Million FDA Contract for Generic Drug Research Funding will support research to create an in vitro/in silico model to accelerate generic drug product development designed for oral cavity administration. Dr. Giovanni Pauletti, Gustavus and predict drug concentrations in human Henry Pfeiffer Chair of Pharmaceutical subjects for generic formulations and Administrative Sciences, professor after administration to the oral cavity of pharmaceutics and associate dean without the use of clinical trials. of graduate studies at the University “Through in vivo studies, generic drug of Health Sciences and Pharmacy in developers measure the blood levels St. Louis (UHSP), has received a $1.2 of medications at various times in million contract from the U.S. Food real people to ensure that the generic and Drug Administration (FDA). The product is bioequivalent to the already funding will support Pauletti’s work to approved innovator product,” Pauletti develop a computational tool with the explained. “These studies take a potential to accelerate the development significant amount of time and are very of generic forms of medications which expensive, so what we’re hoping to do are delivered through the oral cavity. is evaluate bioequivalence though other Over the past five years, Pauletti has types of studies with a combination been conducting research to examine of computer simulations informed by how in vitro systems could be used results from in vitro experiments. This in conjunction with pharmacokinetic approach will utilize mathematical modeling in drug development. equations that we would validate, and Utilizing this three-year FDA contract, these equations will provide us with Pauletti will further extend his data similar to what in vivo studies research by developing an in silico would offer. If we’re successful, this computer modeling and simulation may be a way to get certain drugs, platform with the capability to including those that can be delivered
through the oral cavity, on the market as generics without in vivo studies, which means more rapid access to generic products for patients.”
Making Medications More Readily Available Pauletti’s contract comes from the FDA’s Office of Generic Drugs, which works to ensure—through its scientific and regulatory process—that the U.S. population has access to safe, effective and high-quality generic drugs. In recent years, the organization has been particularly focused on improving physiologically based pharmacokinetic models of drug absorption via complex routes of delivery, including administration via the oral cavity, nose, eye and lungs. Most drug development outside of the United States focuses on generics, since this requires fewer resources, Pauletti pointed out. Rather than performing
Academic Pharmacy NOW 2021 Issue 1
5
