Pharmaceutical Scientist
U.S. Food and Drug Administration
Dr. Yi-Hsien Cheng is a Pharmaceutical Scientist at the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) at the U.S. FDA. She earned her Ph.D. in Bioenvironmental Systems Engineering from National Taiwan University in 2013 and completed postdoctoral fellowships at both National Taiwan University and Kansas State University. Since joining the FDA in 2021, Dr. Cheng has applied physiologically based pharmacokinetic (PBPK) modeling to support regulatory bioequivalence (BE) evaluations for oral drug products. Her work focuses on using PBPK modeling and virtual BE simulations to examine factors influencing BE determination, including parent vs. metabolite selection as the BE analyte, food–formulation interactions, non-comparable dissolution profiles between test and reference listed drug (RLD) products (including in vitro alcohol dose dumping studies), and BE study designs involving single-sex vs. both sexes. Her research supports regulatory decision-making and advances the scientific assessment of generic drug products.