Panchagnula R, Agrawal S, Kaur K J, Singh I, Kaul C L
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, SAS Nagar, Punjab, India.
Int J Tuberc Lung Dis. 2000 Dec;4(12):1169-72.
For an accurate assessment of rifampicin bioequivalence from fixed-dose combinations (FDCs), and to reduce the time and cost constraints associated with bioequivalence studies, the World Health Organization and the International Union Against Tuberculosis and Lung Disease have developed a simplified screening protocol. This study was undertaken with the objective of testing the applicability of this protocol for all types of FDCs. Data were obtained for volunteers common to three studies, and pharmacokinetic parameters were evaluated by different statistical tests. From the results, it has been demonstrated that the simplified screening protocol is suitable for evaluating the bioequivalence of rifampicin in all the types of FDCs available on the market.
为了准确评估固定剂量复方制剂（FDCs）中利福平的生物等效性，并减少与生物等效性研究相关的时间和成本限制，世界卫生组织和国际防痨和肺部疾病联盟制定了一种简化的筛选方案。本研究旨在测试该方案对所有类型FDCs的适用性。获取了三项研究中共同志愿者的数据，并通过不同的统计检验评估药代动力学参数。结果表明，简化筛选方案适用于评估市场上所有类型FDCs中利福平的生物等效性。
