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General Formulation Considerations in Bioequivalence Assessment for Generic Drug Approval

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  • Hongling Zhang, Ph.D.

    Dr. Hongling Zhang is the division director of the Division of Bioequivalence II in the Office of Bioequivalence of OGD, FDA. Since joining OGD in 2008, she has been involved in evaluating bioequivalence (BE) submissions in ANDAs for many complex drug products and BE studies with complex scientific and/or regulatory issues. She is also involved in developing BE guidance of complex drug products, such as MDIs, nasal sprays, ophthalmic emulsions, and some other locally acting drug products, for which in vivo BE study is not suitable or in vivo BE study per se is not sufficient to demonstrate BE. Dr. Zhang received her Ph.D. degree in Pharmacology from the University of South Florida and completed a post-doctoral training at the Moffitt Cancer Institute.

September 22, 2022
Thu 12:30 PM EDT

Duration 1H 30M

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