FDA Fellowship in Generic Opioid Bioequivalence and Safety Research

About the Research Opportunity

A research opportunity is available immediately with the Food and Drug Administration (FDA), in the Center for Drug Evaluation and Research (CDER), located 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.

Research Project

As an Oak Ridge Institute for Science and Education (ORISE) participant, you will join and learn from a community of scientists and researchers engaged in a regulatory science project examining how generic-to-generic switching and food effects contribute to variability in systemic opioid exposure under real-world conditions, using immediate-release (IR) oxycodone as the primary model system. Under the guidance of a mentor, you will have the opportunity to:

• Characterize fed/fasted bioequivalence (BE) variability across approved IR opioid generics using Abbreviated New Drug Application (ANDA) data and identify products with borderline BE or differential food effects
• Evaluate the clinical significance of observed variability in opioid-naive versus opioid-tolerant populations using literature-based exposure-response data
• Investigate biorelevant dissolution methods and an integrated risk-based framework to identify conditions where generic switching may amplify variability

Findings will inform FDA regulatory science on BE evaluation approaches, product-specific guidance, and safe use of opioid generics. The project is led by the Office of Research and Standards (ORS) in the Office of Generic Drugs, CDER.

Learning Objectives

Under the guidance of your mentor, you will:

• Gain understanding of the principles of bioequivalence (BE) and food-effect assessment for IR opioid generic products using ANDA data
• Learn how to analyze variability in systemic opioid exposure associated with fed and fasted conditions across approved IR opioid generics
• Hone skills in identifying characteristics of generic products that demonstrate borderline bioequivalence or differential food effects
• Gain understanding of literature-based exposure–response relationships relevant to opioid-naive and opioid-tolerant populations
• Learn how to assess the potential clinical significance of variability in opioid exposure resulting from generic-to-generic switching
• Develop skills in explaining factors that may contribute to variability in opioid absorption and systemic exposure under real-world conditions
• Gain experience in applying concepts of biorelevant dissolution testing to evaluate formulation performance under physiologically relevant conditions
• Learn how to develop integrated risk-based approaches for assessing variability associated with generic switching
• Hone skills in regulatory science research, scientific literature evaluation, and data interpretation related to opioid product performance
• Develop skills in communicating scientific findings related to bioequivalence, food effects, and formulation variability to multidisciplinary research audiences

Mentor

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

Appointment Details

• Anticipated Start Date: October 2026 (flexible)
• Appointment Length: Initially one year, may be renewed upon recommendation of FDA and contingent on availability of funds
• Level of Participation: Full time
• Citizenship: 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 for information about acceptable immigration statuses. Completion of a successful background investigation by OPM is required; OPM can complete this only for individuals who have resided in the U.S. for a total of three of the past five years.

Qualifications

The qualified candidate should be currently pursuing or have received a doctoral degree (Ph.D., Pharm.D., or equivalent) in pharmaceutical sciences, pharmacokinetics/pharmacology, biopharmaceutics, biostatistics, or a closely related discipline.

Preferred Skills

• Experience in drug absorption, bioequivalence (BE) principles, pharmacokinetic data analysis, and biostatistical methods
• Graduate training in dissolution science, formulation assessment, or quantitative/computational methods
• Familiarity with biorelevant dissolution testing (e.g., fasted/fed state methods, two-stage dissolution)
• Experience in statistical or computational modeling, including biostatistical methods, PBPK, or population-based pharmacokinetic modeling
• Experience with biostatistical analysis relevant to BE studies, such as confidence interval estimation, mixed-effects models, or variability assessment
• Ability to conduct systematic literature reviews and integrate in vitro/in vivo data
• Strong scientific writing skills
• Motivation to participate independently and collaboratively in multidisciplinary settings