*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Division of Applied Regulatory Science (DARS), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Drug-drug interactions occur when one drug (perpetrator) interferes with transport or metabolism of a second drug (victim). This interaction may result in the loss of efficacy or increased toxicity of the victim drug. The project involves utilization of in vitro assays to determine whether drugs are substrates or inhibitors of drug transporters or metabolic enzymes. The results will lead to an understanding of how certain perpetrator drug(s) may alter the disposition and elimination of victim drug(s). Positive results in these assays may indicate a need for further clinical drug-drug interaction studies or changes in drug product labeling.
Under the guidance of a mentor, the participant will learn about the following:
- Planning and performance of in vitro transporter and metabolism assays.
- Bioanalysis of drugs and/or their metabolites in experimental samples.
- Experimental data analysis for transporter and metabolism kinetics and inhibition.
- Drafting of project internal reports and manuscripts.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0633) in your email.