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Generic Oral Modified Release Drug Products: Establishing Bioequivalence for “Additional Strengths”

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Contributors

  • Wei-Jhe Sun, Ph.D.

    Dr. Wei-Jhe Sun started his career in the Office of Generic Drugs within the FDA’s Center for Drug Evaluation and Research in 2018. His primary function has been to conduct regulatory research and reviews to develop product-specific guidance on demonstrating bioequivalence for orally-administered modified release drug products. Prior to joining the FDA, he worked in the pharmaceutical industry as a formulation scientist. Dr. Sun received his M.S. in Pharmaceutical Sciences from the National Taiwan University and Ph.D. in Pharmaceutics from the University of Minnesota. He has a variety of research interests in the field of pharmaceutical sciences, including formulation design, drug delivery, manufacturing sciences and solid-state pharmaceutics and has published well received peer-reviewed journal articles in these areas. Through hands-on work as a formulator and regulatory research and review experiences, Dr. Sun has built extensive knowledge in formulation sciences of oral drug products.

  • Rong Wang, Ph.D.

    Dr. Rong Wang began her regulatory science career at the U.S. Food and Drug Administration (FDA) in 2010. She worked as an ORISE Fellow for approximately two years in the Office of Generic Drugs, Center for Drug Evaluation and Research (CDER) at FDA focusing on addressing inquiries via controlled correspondences from generic drug applicants, assessing bioequivalence study protocols and developing product specific guidance (PSG) with bioequivalence recommendations. Later, Dr. Wang has worked as a pharmacologist in Office of Bioequivalence (OB) in OGD and devoted to bioequivalence assessment of abbreviated new drug applications (ANDAs). Dr. Wang has accrued extensive knowledges and experiences in generic drug bioequivalence assessment as a primary, secondary and tertiary reviewer over the years. Dr. Wang also actively participates in various working groups within the Agency where she has contributed her expertise and experiences in revising or developing general guidance for ANDAs and establishing work process for ANDA assessment.

December 10, 2020
Thu 12:30 PM EST

Duration 1H 30M

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