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<p>Model-informed drug development (MIDD) is a framework that utilizes quantitative modeling and simulation methods to integrate nonclinical and clinical data, as well as prior knowledge, to inform drug development and regulatory decision-making. This scoping review examines the current MIDD landscape with a focus on pharmacometrics. It will clarify essential MIDD concepts and provide a taxonomy of terms. Additionally, it will evaluate the implications of the International Council for Harmonisation (ICH) M15 MIDD draft guidelines and summarize case studies that illustrate the use of MIDD in various drug development and lifecycle management scenarios. The diverse case studies span various therapeutic areas, small molecules, monoclonal antibodies, and long-acting injectable dosage forms. The ICH M15 MIDD guidelines aim to align the expectations of regulators and sponsors, support consistent regulatory decisions, and minimize errors in the acceptance of modeling and simulation. MIDD is a transformative and rigorous process that fosters collaboration between industry and regulatory agencies during drug development.MIDD has enabled accelerated approvals of drugs for pediatric conditions and rare diseases, where it can be difficult to recruit enough patients for efficacy studies. MIDD has contributed to the clinical pharmacology strategies that have successfully allowed dose extrapolation to related disease indications, dosage forms, and clinical populations without additional clinical trials.</p>

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Scoping review of the role of pharmacometrics in model-informed drug development

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年10月15日

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  • Amruta Gajanan Bhat,
  • Euibeom Shin,
  • Amit Roy,
  • Murali Ramanathan

摘要

Model-informed drug development (MIDD) is a framework that utilizes quantitative modeling and simulation methods to integrate nonclinical and clinical data, as well as prior knowledge, to inform drug development and regulatory decision-making. This scoping review examines the current MIDD landscape with a focus on pharmacometrics. It will clarify essential MIDD concepts and provide a taxonomy of terms. Additionally, it will evaluate the implications of the International Council for Harmonisation (ICH) M15 MIDD draft guidelines and summarize case studies that illustrate the use of MIDD in various drug development and lifecycle management scenarios. The diverse case studies span various therapeutic areas, small molecules, monoclonal antibodies, and long-acting injectable dosage forms. The ICH M15 MIDD guidelines aim to align the expectations of regulators and sponsors, support consistent regulatory decisions, and minimize errors in the acceptance of modeling and simulation. MIDD is a transformative and rigorous process that fosters collaboration between industry and regulatory agencies during drug development.MIDD has enabled accelerated approvals of drugs for pediatric conditions and rare diseases, where it can be difficult to recruit enough patients for efficacy studies. MIDD has contributed to the clinical pharmacology strategies that have successfully allowed dose extrapolation to related disease indications, dosage forms, and clinical populations without additional clinical trials.