Dr. Ahmed Zidan is a Senior Research Pharmacologist in the Division of Pharmaceutical Quality Research (DPQR V), Office of Pharmaceutical Quality Research (OPQR), within the Office of Pharmaceutical Quality (OPQ) at the U.S. Food and Drug Administration (FDA). He received his Ph.D. in Pharmaceutics in Zagazig University through a scholarship at Howard University, where his training focused on drug delivery, biopharmaceutics, advanced manufacturing, and formulation science, providing a strong foundation for his work in oral drug product performance and regulatory science. His work focuses on the mechanistic understanding of oral drug product performance and the development of regulatory science frameworks integrating biopredictive dissolution, in vitro–in vivo correlation (IVIVC), and physiologically based pharmacokinetic (PBPK) modeling to support bioequivalence assessment.
Dr. Zidan has led and contributed to multiple FDA translational and research programs addressing complex generic drug development, including modified-release formulations and products where conventional bioequivalence approaches are challenged. He has authored numerous peer-reviewed publications and scientific reports and has delivered invited presentations at national and international scientific conferences on biopharmaceutics and other regulatory science. He has also received several FDA recognition awards for his contributions to advancing the additive manufacturing and regulatory sciences.
