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US Food and Drug Administration

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FDA In Vitro and In Vivo Bioequivalence Fellowship U.S. Food and Drug Administration (FDA) in United States

Degree Level

Postdoc

Field of study

Pharmacology

Funding

Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed subject to FDA recommendation and availability of funds.

Deadline

Mar 30, 2027

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Country

United States

University

US Food and Drug Administration

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Keywords

Pharmacology
Chemistry
Biomedical Engineering
Medical Science
Pharmacy
Regulatory Science
Biopharmaceutics
Bioequivalence
Pharmaceutical Chemistry
In Vivo Testing

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About this position

This fellowship is hosted by the U.S. Food and Drug Administration in the Office of Generic Drugs / Office of Research and Standards within the Center for Drug Evaluation and Research in Silver Spring, Maryland. The project is part of FDA’s effort to improve how generic drugs are evaluated and approved, with a focus on scientific and regulatory questions around bioequivalence.

The research themes include next-generation drug product evaluation for modified- and immediate-release oral formulations, complex pharmaceutical systems involving challenging active and inactive ingredients, methods to improve human subject safety in bioequivalence studies, and innovative biopharmaceutics assessment tools for predictive and quantitative evaluation of bioequivalence and substitutability.

Under mentor guidance, the participant will build a strong understanding of the scientific and regulatory issues involved in establishing bioequivalence for oral modified-release and immediate-release products, including complex drug products. The work also emphasizes collaboration across disciplines to develop novel in vitro, in vivo, and/or in silico study designs.

The mentor for this opportunity is Dongmei Lu, and the research environment is centered on FDA’s regulatory science mission to support safe and effective medicines for the public.

Funding details

Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed subject to FDA recommendation and availability of funds.

What's required

Applicants should have received a doctoral degree (Ph.D., M.D., Pharm.D., or equivalent advanced degree) in a relevant field such as pharmaceutical science, pharmacology, pharmacy, or a related area. The opportunity is open to U.S. citizens, Lawful Permanent Residents, and eligible foreign nationals. Applicants must have lived in the United States for a total of three of the past five years for background investigation purposes, and proof of health insurance is required. All application documents must be in English or accompanied by an official English translation.

How to apply

Apply through the Zintellect opportunity page by clicking APPLY at the bottom of the posting. Submit an application, transcripts, a current resume/CV with publication list, and one educational or professional recommendation. Email [email protected] with the reference code if you have questions.

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