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bioequivalence
相关语句
  生物等效性
    An Assessment of the Bioequivalence in S-sequence Four-period Crossover Design
    基于S×4设计的生物等效性评价
短句来源
    Estimation of sample size in individual bioequivalence
    个体生物等效性检验的样本含量估计
短句来源
  相似匹配句对
    Estimation of sample size in individual bioequivalence
    个体生物等效性检验的样本含量估计
短句来源
    An Assessment of the Bioequivalence in S-sequence Four-period Crossover Design
    基于S×4设计的生物等效性评价
短句来源
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  bioequivalence
The method was successfully applied to investigate the bioequivalence between two kinds of tablets (test versus reference products) in 18 healthy male Chinese volunteers.
      
Bioanalytical laboratories support a range of regulatory studies ranging from early toxicology studies through Phase 1,2 and 3 clinical studies to definitive bioequivalence and bioavailabity studies in support of the marketed product.
      
With a total run-time of 6 minutes, the method was suitable for supporting clinical studies and applied to the analysis of samples from a bioequivalence study.
      
A new sensitive HPLC-FLD method has been developed and validated for the determination of cisapride in human plasma for a bioequivalence study.
      
This method has been successfully used to support a bioequivalence clinical study.
      
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The statistical methods of individual bioequivalence and population bioequivalence are studied. The procedure of individual bioequivalence is given. An example is also given to illustrate that the conclusions of the procedure indibio.m coincide with those in related literature.

研究了评价总体生物等效性和个体生物等效性的统计方法,给出了相应的程序indibio.m,并举例说明indibio.m的运行结果与有关文献一致.

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 cross-over design.When,estimation method is feasible in estimating 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.Consequently,we are able to choose appropriate method to...

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 cross-over design.When,estimation method is feasible in estimating 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.Consequently,we are able to choose appropriate method to estimate sample size.CONCLUSION:Sample size of individual bioequivalence is different as σWR,σD and designs are changed.

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。

 
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