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Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

  • Meeting Report
  • Best Practices for Utilizing Modeling Approaches to Support Generic Product Development: A Series of Workshop Summary Reports
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Abstract

The 2023 Generic Drug Science and Research Initiative Public Workshop organized by the U.S. Food and Drug Administration (FDA) discussed the research needs to improve and enhance bioequivalence (BE) approaches for generic drug development. FDA takes such research needs and panel discussions into account to develop its Generic Drug User Fee Amendments III (GDUFA III) Science and Research Initiatives specific to generics. During the five workshop sessions, presentations and panel discussions focused on identifying and addressing scientific gaps and research needs related to nitrosamine impurity issues, BE assessment for oral products, innovative BE approaches for long-acting injectable products, alternative BE approaches for orally inhaled products, and advanced BE methods for topical products. Specifically, this report highlights the discussions on how to improve BE assessment for developing generic drug products based on research priorities for leveraging quantitative methods and modeling, as well as artificial intelligence/machine learning (AI/ML).

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Acknowledgements

We would like to thank Manar Al-Ghabeish (Division of Therapeutic Performance II, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA) and Priyanka Ghosh (Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA) for their assistance with comments and critical review during the preparation of the manuscript.

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Authors and Affiliations

  1. Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

    Arindom Pal, Fang Wu, Ross Walenga, Eleftheria Tsakalozou, Khondoker Alam, Yuqing Gong, Liang Zhao & Lanyan Fang

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  1. Arindom Pal
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  2. Fang Wu
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  3. Ross Walenga
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  4. Eleftheria Tsakalozou
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  5. Khondoker Alam
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  6. Yuqing Gong
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  7. Liang Zhao
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  8. Lanyan Fang
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Contributions

A. P., F. W., R. W., E. T., K. A., and Y. G. wrote the manuscript. L. Z. and L. F. provided critical feedback and helped in shaping the manuscript. All co-authors contributed to the revision of the manuscript.

Corresponding author

Correspondence to Lanyan Fang.

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The opinions expressed in the article are those of the authors and should not be interpreted as the position of the U.S. Food and Drug Administration.

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The authors declare no competing interests.

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Communicated by Fang Wu and Liang Zhao.

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Pal, A., Wu, F., Walenga, R. et al. Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop. AAPS J 26, 45 (2024). https://doi.org/10.1208/s12248-024-00916-8

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  • DOI: https://doi.org/10.1208/s12248-024-00916-8

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