摘要
目的:对两种设计方法、三种检验方法的个体生物等效性的检验效能进行比较,并估计样本含量。方法:采用Monte-Carlo模拟研究。结果:2×4交叉设计所需的样本含量低于2×3设计。在个体内变异小于0.2时,可以采用估计法进行样本含量的估计;在个体内变异接近0.2时,可以采用检验法进行样本含量的估计;在个体内变异大于0.3时,可以选任一方法(估计法和检验法)估计样本含量,并选择合适的方法进行样本含量的估计。结论:个体生物等效性的样本含量因不同的个体内变异和个体与药物间的交互作用、设计而不同。
AIM： To compare efficacy of two designs and three test approaches in individual bioequivalence and estimate sample size. METHODS： Monte-Carlo simulation research was applied. RESULTS- Sample size under 2 × 4 cross-over design is less than that under 2 × 3 crossover design. When , estimation method is feasible in esti- mating sample size. Whereas is close to 0.2, we can use test method to determine sample size. Then, either method is chosen to determine sample size. are able to choose appropriate method size. CONCLUSION： Sample size equivalence is different as σWR,σD changed. Consequently, we to estimate sample of individual bio- and designs are changed.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2007年第2期204-207,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
