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Youwei Bi, PhD

Team Lead
FDA, MD

Youwei Bi, Ph.D.
Pharmacometrics Team Lead
Dr. Youwei Bi is the Team Lead at the Division of Pharmacometrics, Office of Clinical Pharmacology, Center of Drug Evaluation and Research, FDA. He received his Ph.D. in Clinical Pharmaceutical Sciences and Master’s in Biostatistics from the University of Iowa. He has been reviewing oncology, immunology, and dermatology drug products at FDA since 2016. His primary responsibilities include reviewing IND and NDA applications, assessing the drug dosing at the individual and population levels, and evaluating the application of quantitative methods to support regulatory review, labeling and policy development.

Disclosure(s): No financial relationships to disclose

Presentation(s):

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