FDA Trend Analysis and Data Mining of Bioequivalence Studies Submitted in ANDAs

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at 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. Research Project: This project is in the Office of Study Integrity and Surveillance (OSIS), Office of Transalational Science (OTS). The project is aimed to establish a statistical basis to ensure that the bioequivalence data submitted in Abbreviated New Drug Applications (ANDAs) are sound and comparable to the known clinical pharmacology of the drug. The project will compile historical pharmacokinetic data for select drugs and evaluate drug concentrations and pharmacokinetic parameters based on subject level data. Learning Objectives: Under the guidance of the mentor, the participant will learn the principles, objectives, and conduct of bioequivalence studies submitted in support of ANDAs. The participant will also learn how CDER Offices evaluate bioequivalence studies to ensure that the data supporting generic drug approvals are reliable. The participant will learn and utilize statistical methodologies developed within the Agency to evaluate pharmacokinetic data across multiple ANDA applications. Through this project, the participant will contribute to the overall understanding of drug concentration profiles originating from bioequivalence studies. Anticipated Appointment Start Date: Start date is flexible and will depend on a variety of factors. Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds. Level of Participation: The appointment is full time. 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. This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits. Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years. FDA Ethics Requirements If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists. FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following: Non-employee nature of the ORISE appointment; Prohibition on ORISE Fellows performing inherently governmental functions; Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship; The fact that research materials and laboratory notebooks are the property of the FDA; ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields. Degree must have been received within the past five years, or anticipated to be received by 9/04/2024. Preferred skills/ knowledge: Good understanding of bioequivalence studies Demonstrated analytical skills Strong Familiarity with Excel Data handling skills using R or Python Familiarity with R-Shiny

The application must be completed through Zintellect.