U.S. Food and Drug Administration
Ming-Liang Tan, Ph.D
Reviewer (Staff Fellow), PBPK for Locally Acting Products Team, Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. His current focus is on advancing mechanistic based absorption modeling for locally acting complex drug products, trying to use physiologically based pharmacokinetics (PBPK) modeling methods to establish bioequivalence in lieu of a bioequivalence study with clinical endpoints. Dr. Tan joined FDA in 2015 as an ORISE (Oak Ridge Institute for Science and Education) fellow in the Office of Clinical Pharmacology, Office of Translational Science, CDER, where he had the opportunity to work on several projects within clinical pharmacology, with a focus on PBPK modeling and simulations to predict the drug-drug interaction, pharmacogenetics and renal impairment effect on pharmacokinetics. Prior to the FDA, he worked at Georgetown University as a research faculty and he had an extensive experience in modeling and simulations of molecular structure, dynamics and function for small molecules, peptides and large biologics. Dr. Tan holds a Ph. D degree in molecular physics.
Tuesday, November 5
9:00 AM – 9:30 AM