FDA Bioequivalence of Complex Generic Products Fellowship

Research Project

This research project is related to complex drug substances and complex formulations in the areas of parenteral, intrauterine, intravaginal, ophthalmic, otic, inhalation, nasal, topical, transdermal and transmucosal products to understand the formulations that have been approved under abbreviated new drug applications (ANDAs) and NDAs. The project will identify and develop in vitro, in vivo, or in silico techniques that may be capable of determining how various complexity factors can impact the performance of test products to their respective reference listed drug. It will also identify potential scientific gaps in the application of novel technologies for characterizing complex generic products to support bioequivalence and product development.

Learning Objectives

Under the guidance of the mentor, the participant will gain a comprehensive understanding of the scientific and regulatory challenges that must be considered when establishing bioequivalence for complex generic topical, transdermal and transmucosal drug products. This will include combination drug-device products with device components that may themselves have degrees of complexity in design. In addition, the participant 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.

Mentor

The mentor for this opportunity is Yan Wang (Yan.Wang3@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

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

The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields (e.g. pharmaceutical science, pharmacology, pharmacy, or a related area).

I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

AND

I have read the FDA Ethics Requirements.