Dear Fellow Scientists:
Happy to invite you to the September 2022 BEBAS community webinar on "
General Formulation Considerations in Bioequivalence Assessment for Generic Drug Approval". - Hongling Zhang, Ph.D. US-FDA
Date: September 22, 2022
Time: 12.30 pm -1.30 (EDT)
Please plan on attending this webinar and circulate the information among all interested parties. Please pre-register at General Formulation Considerations in Bioequivalence Assessment for Generic Drug Approval | AAPS
Abstract: A generic drug product and its reference listed product (RLD) can differ in excipients, formulation design and manufacture process. The design of a formulation and use of certain excipients may have a significant impact on the efficacy and/or safety of the drug product, thus making the test product not bioequivalent (BE) to the RLD or reference standard (RS). This presentation will use case studies to demonstrate the role of formulation design in BE recommendations and during the BE assessment for ANDA applications. This information will help the generic drug applicants to understand the factors that should be considered during product development and ensure that the test product is bioequivalent to the RLD or reference standard (RS).
Speaker's BioSketch:
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.
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Prasad Tata M. Pharm, Ph.D., FCP
Sr. Director-PK/BE
American Regent, Inc.
Princeton NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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