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Clinical study for medicine products is a time-consuming and high-cost project. As a great tool of optimizing trial design, simulation technology plays an important role in different phases and different indications of clinical trials. At present, different regulatory agencies have established corresponding technical requirements for simulation technology. This paper summarized the development of the guidelines of NMPA, FDA, EMA, and ICH to elaborate the regulatory status of simulation technology. Without additional clinical trial data, one pharmaceutical company successfully expanded the indications of adalimumab in adults for hidradenitis suppurativa to adolescent by virtue of only model simulation results. This article analyzed this case in detail to illustrate the importance of simulation technology. Finally, this paper discussed the advantages and disadvantages of simulation technology, as well as the considerations in practical application.

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药物临床研究具有耗时长和成本高的特点。模拟技术作为优化试验设计的重要手段，在不同阶段和不同适应证的临床研究中均发挥较大作用。当前国内外监管机构均已建立了针对模拟技术的相应技术要求，本文通过总结中国、美国、欧盟和国际人用药品注册技术协调会的指导原则制定进展，阐述了当前模拟技术的监管现状。某制药公司在未提供额外临床试验数据的情况下，仅通过模型模拟结果成功将阿达木单抗在成人中的化脓性汗腺炎适应证扩展至青少年。本文详细分析了该案例的桥接方法以说明模拟技术在当前临床研究中的重要性。最后本文讨论了模拟技术的优缺点，以及在实际应用中的考虑。

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李若冰，男，助理研究员，主要从事药品的技术审评工作。联系电话：(010)85243215，E-mail: lirb@cde.org.cn。

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李若冰，男，助理研究员，主要从事药品的技术审评工作。联系电话：(010)85243215，E-mail: lirb@cde.org.cn。

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