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高变异药物等效性评估方法在Excel中的实现

Evaluation of Bioequivalence for Highly Variable Drugs by Excel
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摘要 目的:使用Excel建立一种简易高效的高变异药物生物等效性评估方法。方法:利用Excel内置的统计分析函数,对数据进行单因素方差分析、90%置信区间、单侧95%置信区间上限等统计学检验。结果:基于Excel进行高变异药物的生物等效性检验,其得出的结果个体内变异系数、90%置信区间和单侧95%置信区间上限与Phoenix WinNonlin结果一致。结论:高变异药物等效性评估方法在Excel中可以实现,且整个数据处理过程高效快捷、结果可靠,是处理高变异药物生物等效性试验数据的一种理想方法。 Objective:A simple and efficient bioequivalence evaluation for highly variable drugs was established by Excel.Methods:The built-in statistical analysis function of Excel was used to perform statistical tests such as one-way ANOVA,90%confidence limit and upper 95%confidence limit based on the data.Results:The bioequivalence evaluation of highly variable drugs was conducted by Excel,and the within-subject variation,90%confidence limit and upper 95%confidence limit were consistent with the results of Phoenix WinNonlin.Conclusion:The bioequivalence evaluation for highly variable drugs can be realized in Excel,and the whole data processing process is efficient,fast and reliable,which is an ideal method to process the bioequivalenc data for highly variable drugs.
作者 唐韵 王杰 苏远 吴昭君 何鸽飞 TANG Yun;WANG Jie;SU Yuan;WU Zhao-jun;HE Ge-fei(Department of Pharmacy,The First Hospital of Changsha,Hunan Changsha 410013,China)
出处 《中国药物评价》 2024年第2期124-127,共4页 Chinese Journal of Drug Evaluation
关键词 高变异药物 参比制剂校正平均生物等效性 生物等效性 单因素方差分析 EXCEL Highly variable drugs Reference-scaled average bioequivalence Bioequivalence One-Way ANOVA Excel
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