生物等效性试验中药代动力学报表自动输出的SAS实现

Realization of automatic output of pharmacokinetic reports for bioequivalence test by SAS

目的为满足药物一致性评价中药代动力学(PK)参数生物等效性分析计算以及结果报表规范化自动输出。方法将SAS的数据处理功能与输出交付系统相结合,编写自动输出PK参数统计分析报表的SAS宏程序%AbeTable。结果以加拿大卫生部发布有关文件中的PK数据为实例,程序计算结果准确,输出的统计报表格式规范,符合临床试验统计分析报告的基本要求。结论宏%AbeTable具有较好的通用性,结果可靠,生成报表效率高,可以满足生物等效性分析的统计需要。

Objective To satisfy the analysis and calculation of bioequivalence and pharmacokinetics(PK)parameters for drug consistency evaluation,and to realize the standardized automatic output of result reports.Methods The data processing function of Statistical Analysis System(SAS)was combined with the output delivery system to program the SAS macro program,%Abe Table,for automatic output of statistical analysis reports of PK parameters.Results Taking the PK data in the relevant documents released by Health Canada as an example,the output statistical reports was standardized in format if the results calculated by the program were accurate,which met the basic requirements of statistical analysis reports of clinical trials.Conclusion The macro program%Abe Table has good generality with reliable results,and high efficiency in generating reports,which can meet the statistical requirements of bioequivalence analysis.