Abstract
Evidence shows that there is an increasing use of modeling and simulation to support product development and approval for complex generic drug products in the USA, which includes the use of mechanistic modeling and model-integrated evidence (MIE). The potential for model reuse was the subject of a workshop session summarized in this review, where the session included presentations and a panel discussion from members of the U.S. Food and Drug Administration (FDA), academia, and the generic drug product industry. Concepts such as platform performance assessment and MIE standardization were introduced to provide potential frameworks for model reuse related to mechanistic models and MIE, respectively. The capability of models to capture formulation and product differences was explored, and challenges with model validation were addressed for drug product classes including topical, orally inhaled, ophthalmic, and long-acting injectable drug products. An emphasis was placed on the need for communication between FDA and the generic drug industry to continue to foster maturation of modeling and simulation that may support complex generic drug product development and approval, via meetings and published guidance from FDA. The workshop session provided a snapshot of the current state of modeling and simulation for complex generic drug products and offered opportunities to explore the use of such models across multiple drug products.
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Notes
Videos and slide presentations are available: https://www.complexgenerics.org/modeling-approaches/
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Acknowledgements
The authors are grateful for the contributions of the Center for Research on Complex Generics (CRCG) for their valuable assistance with planning and running the workshop.
Funding
This workshop was supported by the Food and Drug Administration (FDA) of the US Department of Health and Human Services (HHS) as part of a financial assistance award U18FD007054 totaling $1,000,000 with 100% funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the US Government.
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Workshop session planning and execution: all co-authors. Manuscript development lead: Ross Walenga. Introduction, panel discussion, and conclusion: Ross Walenga. Presentations: Andrew Babiskin, Miyoung Yoon, James Clarke, Marc Kelly, Ross Walenga, Maxime Le Merdy, and Murray Ducharme. Manuscript review and revision: all co-authors.
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Communicated by Fang Wu and Liang Zhao.
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Walenga, R.L., Babiskin, A.H., Bhoopathy, S. et al. Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products. AAPS J 26, 12 (2024). https://doi.org/10.1208/s12248-023-00879-2
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DOI: https://doi.org/10.1208/s12248-023-00879-2