Dr. Xinyuan Zhang

Xinyuan Zhang, Ph.D., is a PBPK co-lead in the Division of Pharmacometrics (DPM)/ Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences (OTS) / CDER. She shares responsibility for scientific oversight of PBPK review activities and provides leadership in PBPK-related research in OCP. Prior to joining OCP in 2017, Dr. Zhang was a Scientific Lead for absorption modeling in the Office of Research and Standards (ORS)/ Office of Generic Drugs (OGD) where she focused on applying PBPK and absorption modeling and simulation to address issues in Abbreviated New Drug Application (ANDA) reviews, controlled correspondences, citizen petitions, and bioequivalence guidance development.  She has co-authored over 40 research and review articles and 3 book chapters with some of them focusing on PBPK and absorption modeling and simulation and its application in regulatory sciences. She received her Ph.D. from the University of Michigan, Ann Arbor.