*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality/ Office of Testing and Research (OTR), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The project will develop a biopredictive in vitro permeation test (IVPT) and an in vitro in vivo extrapolation (IVIVE) model for an intranasal drug product. The goal of the project is to evaluate the feasibility of using an IVPT as a surrogate for an early stage clinical pharmacokinetic study of that intranasal drug product.
The participant will gain an understanding about the current regulatory requirements and the assessment of innovator and generic nasal spray products. The opportunity will also expand the participant’s knowledge about in vitro permeability, pharmacokinetic modeling and nasal drug delivery.
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 (FDA-CDER-2021-0611) in your email.