论文部分内容阅读
为了对固定剂量复合制剂(fixed-dosecombinations,FDCs)中利福平生物当量(bioequivalence)精确地检验,并减少与生物当量研究有关的时间及成本的制约,世界卫生组织及国际防痨和肺部疾病联合会推出一项简化的筛查方案。此项研究承担了该方案对所有类型FDCs测试其适用性的目的。普通志愿者获得的三项研究数据,及药代动力学参数经不同的统计检测予以评价。从结果上看,已证实简化的筛查方案对在市场上可获得的所有类型FDCs中利福平的生物当量予以评价是合适的。
In order to accurately test the bioequivalence of fixed-dose combinations (FDCs) and to reduce the time and cost associated with bioequivalence studies, the World Health Organization and the International Ataxia and Lung The Federation of Diseases unveils a simplified screening program. The study assumed the program’s goal of testing suitability of all types of FDCs. The three study data obtained by general volunteers and the pharmacokinetic parameters were evaluated by different statistical tests. From a result point of view, it has been found that a simplified screening protocol is suitable for evaluating the bioequivalence of rifampin in all types of FDCs available on the market.