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<p>This overview summarizes the history and advancements of the modeling and simulation programs utilized in drug development and regulatory assessment, including the FDA’s Model-Informed Drug Development (MIDD) Paired Meeting Program and the Model-Integrated Evidence (MIE) Meeting Pilot Between FDA and Generic Drug Applicants. The U.S. Food and Drug Administration’s (FDA) recent&#xa0;notice concerning the use of the Type V Drug Master File (DMF) for Model Master File (MMF) submissions to support abbreviated new drug applications (ANDAs) encourages and facilitates model-sharing and model-reusability in drug development, supporting MIE programs using a broad range of quantitative models, including, but not limited to physiologically based pharmacokinetic (PBPK), population pharmacokinetics (PPK) and computational fluid dynamics (CFD) modeling. This overview also introduces the considerations and representative mock examples of MMFs discussed in the workshop titled “Considerations and Potential Regulatory Applications for a Model Master File (MMF)” co-hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on May 2–3, 2024. MMFs promote modeling and simulation approaches by reducing the burden of resources in developing this type of approaches for the pharmaceutical&#xa0;industry while increasing consistency and efficiency in regulatory assessments.</p>

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Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use

  • 期刊论文

  • 发表日期：

    2025年5月1日

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  • Lanyan Fang,
  • Eleftheria Tsakalozou,
  • Fang Wu,
  • Daniel Ritterbeck,
  • Liang Zhao,
  • Lei Zhang,
  • Robert Lionberger

摘要

This overview summarizes the history and advancements of the modeling and simulation programs utilized in drug development and regulatory assessment, including the FDA’s Model-Informed Drug Development (MIDD) Paired Meeting Program and the Model-Integrated Evidence (MIE) Meeting Pilot Between FDA and Generic Drug Applicants. The U.S. Food and Drug Administration’s (FDA) recent notice concerning the use of the Type V Drug Master File (DMF) for Model Master File (MMF) submissions to support abbreviated new drug applications (ANDAs) encourages and facilitates model-sharing and model-reusability in drug development, supporting MIE programs using a broad range of quantitative models, including, but not limited to physiologically based pharmacokinetic (PBPK), population pharmacokinetics (PPK) and computational fluid dynamics (CFD) modeling. This overview also introduces the considerations and representative mock examples of MMFs discussed in the workshop titled “Considerations and Potential Regulatory Applications for a Model Master File (MMF)” co-hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on May 2–3, 2024. MMFs promote modeling and simulation approaches by reducing the burden of resources in developing this type of approaches for the pharmaceutical industry while increasing consistency and efficiency in regulatory assessments.