| 生物等效性研究的统计分析数据核查及敏感性分析 |
| 投稿时间：2022-12-20 修订日期：2023-05-30 点此下载全文 |
| 引用本文：李林鹤.生物等效性研究的统计分析数据核查及敏感性分析[J].药学实践杂志,2023,41(6):377~379 |
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| 中文摘要:目的 通过对18项生物等效性研究统计分析数据的核查，梳理核查的要点、问题及对策，为完善相关研究的统计分析报告提供参考。方法 运用SAS、WinNonlin软件，核查研究分组的随机数字表、药代动力学主要参数以及生物等效性的分析，计算数据能否重现原统计分析报告的相应结果。结果 18项研究中，5项因个别受试者采样时间偏差或敏感性数据集的调整、补充或重新进行了敏感性分析，导致药代动力学参数与原统计分析报告有所差异，但敏感性分析的结果维持原统计分析报告的生物等效性评价；其他核查的数据均与原统计分析报告一致。结论 生物等效性研究统计分析数据的核查极为重要，在撰写该类统计分析报告时，对本核查中发现的问题应予以充分的考虑。 |
| 中文关键词:生物等效性 统计分析 数据核查 敏感性分析 |
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| Data verification and sensitivity analysis of statistical analysis in bioequivalence studies |
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| Abstract:Objective To sort out the key points, problems and countermeasures of data verification through data verification of statistical analysis in 18 bioequivalence studies, and provide reference for improving the statistical analysis reports of related research. Methods SAS and WinNonlin software was used to illustrate that whether the random number tables, main pharmacokinetic parameters and bioequivalence data could reproduce the corresponding results in the original statistical analysis reports. Results Among the 18 studies, sensitivity analysis was supplemented or re-performed for 5 studies due to sampling time deviation of individual subjects or adjustment of sensitivity data sets, resulting in differences in pharmacokinetic parameters from the original statistical analysis report, but same for the bioequivalence evaluation. Other verified data was consistent with the original statistical analysis reports. Conclusions The verification of statistical analysis data of bioequivalence studies is extremely important, and the problems found in this paper should be fully considered when writing such statistical analysis reports. |
| keywords:bioequivalence studies statistical analysis data verification sensitivity analysis |
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