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Research Project Description

Drug-Drug Interactions Fellowship
Division of Clinical Pharmacology IV
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD

FDA-CDER-2014-0048

Project Description:

A fellowship opportunity is currently available in the Division of Clinical Pharmacology IV within the Office of Clinical Pharmacology (OCP) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).

OCP’s mission is to assure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and biopharmaceutics data in support of CDER’s Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs.

Transporter based drug-drug interactions (DDIs) are being increasingly recognized during drug development and regulatory review. The draft DDI Guidance outlines several decision trees that may be used to determine if an investigational drug is a substrate and/or inhibitor of transporters based on in vitro data and whether follow up in vivo DDI trials are needed.

The objectives of the project are to apply the “cut off” criteria outlined in the various decision trees to the in vitro and in vivo pharmacokinetic data of antiviral drugs and compare the DDI predictions with the observed data from in vivo DDI trials.

The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for four months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.

Qualifications:

  • A Doctoral degree in pharmacy received within the last five years.
  • Background in pharmaceutical sciences and drug development, preferably in the area of drug metabolism and drug transporters, is necessary.

How to Apply:

To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0048 in all communications.