FDA Innovative Drug Release Testing Fellowship

A research opportunity is available in the Office of Pharmaceutical Quality / Office of Testing and Research, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

Pharmaceutical dosage forms have become increasingly complex and the task of developing the right tools to characterize these complex dosage forms have become more challenging. In vitro release test (IVRT) has gained more attention and weight in the regulatory decision-making process for the approval of complex drug products, e.g., nanoemulsions, suspensions, multivesicular liposomes, microspheres etc., as it provides key information about the quality and performance of drug products. Developing a fit-to-purpose, appropriate and robust IVRT method for such complex dosage forms has been an on-going issue for several decades and remains a challenging task for the pharmaceutical industry as well as for the regulatory agency. The overall objective of this research is to explore, develop, optimize and validate a novel IVRT approach/technique of conducting in vitro drug release test for complex drug products.

Under the guidance of a mentor, the participant will receive training to develop advanced and novel in vitro methods to support bioequivalence and pharmaceutical equivalence for generic products with complex formulations and will learn about experimental design, testing and assessment using in vitro models.

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.

The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. 

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0523) in your email.