医学教育管理 ›› 2025, Vol. 11 ›› Issue (1): 26-31.doi: 10.3969/j.issn.2096-045X.2025.01.005

• 教育教学 • 上一篇    下一篇

虚拟药物一致性评价在临床药物代谢动力学实验教学中的应用

龚晶雯,  王舒婷,  许敏生,  苏光宏,  郑运思*   

  1. 海南医科大学药学院,海口 571199
  • 收稿日期:2024-06-12 出版日期:2025-02-20 发布日期:2025-03-19
  • 通讯作者: 郑运思 E-mail:hy0207125@hainmc.edu.cn
  • 基金资助:
    1.海南医学院临床药学专业班主任工作室项目(SA2300003461);2.海南医学院实验教学平台培育项目(DC2300003465)

Application of virtual bioequivalence study in clinical pharmacokinetic experiment teaching

Gong Jingwen, Wang Shuting, Xu Minsheng, Su Guanghong, Zheng Yunsi*   

  1. School of Pharmacy, Hainan Medical University, Haikou 571199, China
  • Received:2024-06-12 Online:2025-02-20 Published:2025-03-19

摘要: 临床药物代谢动力学在药物研发和临床应用中的重要性和学科地位不容忽视,是药物一致性评价的重要基础。然而,传统的实验教学方法由于资源限制和伦理问题等挑战,难以满足新时代的教学需求。本文利用虚拟实验教学技术,模拟达比加群酯胶囊的药物一致性评价实验过程,开展了包括生物等效性试验设计、药代动力学参数计算、方法学验证及生物等效性评价等教学实验改革,探索虚拟实验在临床药物代谢动力学实验教学中的应用和效果。结合教师评价、学生互评、实验报告、期末成绩和调查问卷结果,证明虚拟药物一致性评价试验能够激发学生的学习兴趣,提高其实践操作能力和科学思维能力。虚拟药物一致性评价技术的应用显著改善了临床药物代谢动力学实验课程的学习体验和教学效果,该方法不仅解决了传统实验教学中的资源和伦理问题,为临床药学教育提供了新的思路和方法,还有助于培养符合现代药物研发需求的高素质临床药学专业人才,推动临床药学教育的发展。

关键词: 虚拟实验, 药物一致性评价, 临床药学, 药物代谢动力学

Abstract: The significance and disciplinary status of clinical pharmacokinetics in drug development and clinical applications are undeniable, forming a crucial theoretical basis for drug bioequivalence study. However, traditional experimental teaching methods, challenged by resource limitations and ethical concerns, fail to meet the educational demands of the new era. This article employs virtual experiment technologies, using the simulation of the bioequivalence evaluation of Dabigatran Etexilate Capsules as a case study, to design a series of instructional experiments. These include the design of bioequivalence trials, calculation of pharmacokinetic parameters, methodological validation, and bioequivalence assessment, exploring the application and effectiveness of virtual experiments in clinical pharmacokinetics experimental teaching. Integrating teacher evaluations, peer assessments, experimental reports, final grades, and survey results, it is demonstrated that virtual drug bioequivalence evaluation trials can stimulate students' interest in learning, enhance their practical skills, and improve their scientific abilities. The application of virtual drug bioequivalence evaluation technology significantly enhances the teaching outcomes in pharmacokinetics and enriches the students' learning experience. This technology not only addresses the resource and ethical issues present in traditional experimental teaching but also provides new approaches and methods for clinical pharmacy education. Furthermore, it aids in cultivating high-quality professionals who meet the demands of modern drug development, thereby advancing clinical pharmacy education.

Key words: virtual experiment, drug bioequivalence study, clinical pharmacy, pharmacokinetics

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