平均生物等效性试验设计方法评价

Comparison of Designs for Establishing Average Bioequivalence

目的 比较 6种不同的平均生物等效性试验的设计方法的检验效能与所需的样本含量。方法 采用Monte Carlo方法 ,对不同参数组合下 ,6种设计方法的检验效能或样本含量进行模拟。结果 6种平均生物等效性评价试验的设计方法中 ,以 4× 4交叉设计的效率最高 ,而平行组设计和Balaam设计的效率较低。在相同参数组合下 ,所需的样本含量由少到多的顺序为 :4× 4交叉设计、2× 4交叉设计、2× 3交叉设计、2× 2交叉设计、平行组设计和Balaam设计。结论 对于平均生物等效性而言 ,采用 4× 4交叉设计或 2× 4交叉设计效果较好。

Objective To compare the powers and sam ple size requirements of six designs to establish average bioequivalence.Methods Monte-Carlo simulations was used for all six desig ns with difference parameters grid.Results The most powerful design to establishing average bi oequivalence is 4×4 cross-over design.For six designs,the powers of design met hods in descending:4×4 cross-over disign,2×4 cross-over disign,2×3 cross-o ver design,2×2 cross-over design,parallel design and Balaam's design,while the requirement of the number of total sample size is in contrast order.Conclusion The 4×4 and 2×4 cross-over design are recomme nded to establishing average bioequivalence.