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<p>Population pharmacokinetic/pharmacodynamic (PPK/PD) modeling is a key component of model-informed drug development and model-informed precision dosing. Regulatory agencies in the United States, Europe, Japan, and China, together with the recently adopted ICH M15 guideline, have established high-level principles for the conduct, evaluation, and reporting of population modeling analyses. However, many practical implementation details are intentionally left to sponsors, investigators, and analysts. Although this flexibility accommodates diverse objectives, data structures, therapeutic areas, and decision contexts, it may also contribute to inter-analyst variability and limit the reproducibility, transparency, and consistency of PPK/PD practice. This review discusses the 2025 Chinese Pharmacological Society group standard for PPK/PD analysis from an international and implementation-oriented perspective. The standard describes a stepwise analytical lifecycle comprising pre-analysis preparation, base model development, final model establishment, model application, and reporting, with model evaluation embedded iteratively throughout the process. It also formalizes operational elements often implicit or under-specified in existing guidance, including a prospective Population Modeling Analysis Plan, distinction between exploratory and confirmatory analyses, prioritization of decision-relevant parameters, staged verification checkpoints, a five-element risk-management cycle, and ethical considerations related to data governance and equitable model application. We position the Chinese group standard as an analyst-level operational reference that complements, rather than replaces or duplicates, the decision-level assessment framework provided by ICH M15. Although developed within the Chinese regulatory and professional context, the structured workflow described in the standard may provide a practical reference for organizations seeking to improve the reproducibility, transparency, and consistency of PPK/PD analyses internationally.</p>

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Bridging the operational gap in population pharmacokinetic-pharmacodynamic analysis: an international perspective on the 2025 Chinese group standard

  • 期刊论文

  • 发表日期：

    2026年7月6日

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  • Zheng Jiao,
  • Jun-jie Ding,
  • Guang-li Ma,
  • Xuan Zhou,
  • Lu-jin Li,
  • Kun Wang,
  • Liang Li,
  • Yu-peng Ren

摘要

Population pharmacokinetic/pharmacodynamic (PPK/PD) modeling is a key component of model-informed drug development and model-informed precision dosing. Regulatory agencies in the United States, Europe, Japan, and China, together with the recently adopted ICH M15 guideline, have established high-level principles for the conduct, evaluation, and reporting of population modeling analyses. However, many practical implementation details are intentionally left to sponsors, investigators, and analysts. Although this flexibility accommodates diverse objectives, data structures, therapeutic areas, and decision contexts, it may also contribute to inter-analyst variability and limit the reproducibility, transparency, and consistency of PPK/PD practice. This review discusses the 2025 Chinese Pharmacological Society group standard for PPK/PD analysis from an international and implementation-oriented perspective. The standard describes a stepwise analytical lifecycle comprising pre-analysis preparation, base model development, final model establishment, model application, and reporting, with model evaluation embedded iteratively throughout the process. It also formalizes operational elements often implicit or under-specified in existing guidance, including a prospective Population Modeling Analysis Plan, distinction between exploratory and confirmatory analyses, prioritization of decision-relevant parameters, staged verification checkpoints, a five-element risk-management cycle, and ethical considerations related to data governance and equitable model application. We position the Chinese group standard as an analyst-level operational reference that complements, rather than replaces or duplicates, the decision-level assessment framework provided by ICH M15. Although developed within the Chinese regulatory and professional context, the structured workflow described in the standard may provide a practical reference for organizations seeking to improve the reproducibility, transparency, and consistency of PPK/PD analyses internationally.