Clinical Pharmacometrics Team Lead
US Food & Drug Administration
Dr. Yuching Yang is the Team Lead of the PBPK (Physiologically-Based Pharmacokinetic) and QSP (Quantitative Systems Pharmacology) Modeling Program within the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, at the Food and Drug Administration (FDA). She earned her Ph.D. in Exposure Assessment and Biomedical Science from Rutgers University in 2006. With nearly 20 years of experience, she has specialized in developing and applying mechanistic models in toxicology (PBPK), human risk assessment (PBPK/Bayesian), and clinical drug development (PBPK/QSP). Dr. Yang joined the FDA in December 2015. Her primary responsibilities include evaluating the applicability of PBPK/QSP modeling submitted in INDs, NDAs, and BLAs across multiple therapeutic areas to support clinical drug development, regulatory approval, and policy development.
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Saturday, September 7, 2024
8:00 AM – 5:00 PM ET
6 - Regulatory Perspectives on the Use of PBPK Modeling
Saturday, September 7, 2024
8:00 AM – 5:00 PM ET