| 引用本文: | 孙华,徐毛迪,梁大虎,李相鸿,谢海棠.生物等效性预试验的设计与结果评估[J].中国现代应用药学,2022,39(15):2028-2033. |
| SUN Hua,XU Maodi,LIANG Dahu,LI Xianghong,XIE Haitang.Design and Result Evaluation of Pilot Bioequivalence[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(15):2028-2033. |
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| 摘要: |
| 生物等效性预试验结果可用于优化正式试验的试验方案，评估受试制剂开展正式试验的可行性，预测正式研究的样本量，在仿制药的临床开发中起着越来越重要的作用。缺乏完善设计和合理分析的预试验结果可能会对仿制药与原研药的真实差异及药动学参数的个体内变异大小做出错误估计，进而影响后续开发策略。参考国内外相关文献及指南，本文对生物等效性预试验的设计和评价方法进行系统阐述，重点分析如何对预试验的结果进行科学解读，为申请人开展相关研究提供参考。 |
| 关键词: 生物等效性预试验 自助抽样 预试验可接受置信区间 体内体外相关性 生理药动学模型 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.15.019 |
| 分类号:R969.1 |
| 基金项目:皖南医院中青年科研基金项目（WK2012F26）；皖南医学院科技创新团队-“攀峰”培育计划项目（KPF2019016） |
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| Design and Result Evaluation of Pilot Bioequivalence |
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SUN Hua, XU Maodi, LIANG Dahu, LI Xianghong, XIE Haitang
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Center for Drug Clinical Evaluation, Yijishan Hospital Affiliated to Wannan Medical College, Wuhu 241000, China
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| Abstract: |
| The result of pilot bioequivalence can be used to optimize the protocol of pivotal study, evaluate the feasibility of the test preparations to carry out pivotal trial, and predict the sample size of pivotal study, which plays an increasingly important role in the clinical development of generic drugs. The pilot bioequivalence study lack of well-established design and analysis methods may make a wrong estimate of true test-reference ratio and intrasubject variability, thus affecting the subsequent development strategy. In this review, based on relevant literatures and guidelines, the design and statistical method of pilot bioequivalence were systematically described. The review focused on how to scientifically evaluate the pharmaceutical development strategy of generic drugs based on the results of pilot study, so as to provide reference for applicants. |
| Key words: pilot bioequivalence bootstrap pilot acceptance range in vitro-in vivo correlation(IVIVC) physiologically based pharmacokinetic(PBPK) |
