When researchers from the University of Maryland School of Pharmacy (UMSOP) were asked to attend a Food and Drug Administration (FDA) virtual meeting in September, they didn’t anticipate being recognized during the proceedings. In a pleasant surprise, they learned that work they’d done spanning almost five years on injectable iron drugs had resulted in a change in FDA draft guidance.
The FDA guidance on studies involving injectable ferric oxyhydroxide was changed to allow drug companies to use a crossover clinical trial — rather than just a more conservative parallel trial — and the LC-ICP-MS (liquid chromatography-inductively coupled plasma-mass spectrometry) method, which allows for direct detection of iron nanoparticle drugs in participant samples to demonstrate that a generic product is equivalent to a brand-name drug.
Sarah Michel, PhD, professor of pharmaceutical sciences (PSC) and associate dean for graduate programs at the School of Pharmacy, devised the LC-ICP-MS method, which was used in a crossover study on iron nanoparticle drugs led by James Polli, PhD, the School’s Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics, and Jeffrey Fink, MD, MS, professor of medicine and division head, General Internal Medicine, University of Maryland School of Medicine. In addition, Maureen Kane, PhD, associate professor in PSC and director of the School’s Mass Spectrometry Center, and her lab performed experiments to identify any secondary effects of drug administration.