*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Generic Drugs/ Office of Research and Standards (ORS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
Current product-specific guidance recommendations for demonstrating bioequivalence (BE) of potential generic dry powder inhalers (DPIs) use a weight-of-evidence approach that includes in vitro tests such as aerodynamic particle size distribution and single actuation content, as well as in vivo studies such as a pharmacokinetic study and a pharmacodynamic (PD) or a comparative clinical endpoint (CCEP) study. However, PD/CCEP studies may be prohibitive due to the expected need for large numbers of subjects. A greater understanding of aerosol behavior is needed to consider BE approaches that may not include recommendations for PD/CCEP studies. Computational fluid dynamics (CFD) and discrete element method modeling (DEM) may be used to increase understanding.
Under the guidance of the mentor, the participant will gain knowledge of DEM modeling and be provided with the means to integrate DEM modeling with CFD. The participant will also learn how DPI systems work and how CFD-DEM modeling may be used to increase understanding of these systems. The participant will learn about pharmaceutical drug development and regulation, and the participant will be given opportunities to publish results.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.