FDA In Vitro and In Vivo Bioequivalence Fellowship

Research Project

The research projects seek to transform how FDA evaluates and approves generic drugs through research in:

• Next-Generation Drug Product Evaluation - Revolutionizing regulations for modified and immediate-release oral formulations;
• Complex Pharmaceutical Systems - Tackling research questions involving challenging active/inactive ingredients, sophisticated formulations, and innovative dosage forms;
• Advance Human Subject Safety for Bioequivalence Studies - Conducting meta-analysis to determine appropriate safety strategies to ensure subject safety; and
• Innovative Biopharmaceutics Assessment Tools - Developing predictive and quantitative methodologies for bioequivalence and substitutability evaluation.

Mentor

The mentor for this opportunity is Dongmei Lu (Dongmei.Lu@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Learning Objectives

Under the guidance of the mentor, you will gain a comprehensive understanding of the scientific and regulatory challenges that must be considered when establishing bioequivalence for oral modified and immediate-release products, including complex drug products. In addition, you will gain knowledge in collaborating with cross-disciplinary teams to develop novel in vitro, in vivo, and/or in silico study designs for establishing bioequivalence with these products.

Citizenship Requirements

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

Qualification Requirements

• The qualified candidate should have received a doctoral degree (Ph.D., M.D., Pharm.D., or equivalent advanced degree) in one of the relevant fields (e.g. pharmaceutical science, pharmacology, pharmacy, or other related areas).
• The candidate should have lived in the United States for at least 36 out of the past 60 months.
• The candidate should have read the FDA Ethics Requirements.

Contact Information

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

Application Process

To submit your application, scroll to the bottom of this opportunity and click APPLY.

Additional Resources

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