摘要
在以药动学参数为终点的平均生物等效性试验中样本量是非常重要的,本研究综述了国内外对平均生物等效性试验样本量的法规要求,探讨了平均生物等效性试验样本量的影响因素、估算方法、对试验结果的影响等问题,提出了确定平均生物等效性试验样本量的建议。
Sample size is very important in average bioequivalence tests which use pharmacokinetic parameters as endpoints. In this paper,the registration requirements on sample size,both at home and abroad,were summarized. The influencing factors and calculation methods of sample size,the effect of sample size on the test results,and other problems of average bioequivalence tests were also discussed. Finally,some suggestions on determination of the sample size in average bioequivalence tests were proposed.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2015年第23期2692-2694,2728,共4页
Chinese Journal of New Drugs
关键词
平均生物等效性
药动学
样本量
仿制药
average bioequivalence
pharmacokinetics
sample size
generic drugs