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医药卫生方针政策与法律法规研究
药学
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average bioequivalence
相关语句
  平均生物等效性
     Conclusion The 4×4 and 2×4 cross-over design are recomme nded to establishing average bioequivalence.
     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。
短句来源
     Comparison of Designs for Establishing Average Bioequivalence
     平均生物等效性试验设计方法评价
短句来源
     Objective To compare the powers and sam ple size requirements of six designs to establish 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。
短句来源
     A series of draft guidance of the FDAof US are expected to replace average bioequivalence with individual bioequivalence.
     美国食品与药品管理委员会颁发了一系列的指导草案旨在用个体生物等效性代替现行的平均生物等效性
短句来源
     In chapter 3, the problem of over-variability, which is often overlooked during evaluating the average bioequivalence of high variability medicines and a method to test the variability of the medicines has been recommended by using the Schwarz information criterion in change point. Comparison between two examples is given to test the reliability of this method.
     本文第三章分析了高变异性药物在进行平均生物等效性评价时易被忽视的变异性过大问题,并运用转变点中的Schwarz 信息准则方法给出了检验药物变异性大小的方法,随后用两个实例对比说明了该方法的可行性;
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  相似匹配句对
     in average;
     平均为0.89d。
短句来源
     Comparison of Designs for Establishing Average Bioequivalence
     平均生物等效性试验设计方法评价
短句来源
     (2) The average I.
     2.恶性肿瘤非缓解期I.
短句来源
     A series of draft guidance of the FDAof US are expected to replace average bioequivalence with individual bioequivalence.
     美国食品与药品管理委员会颁发了一系列的指导草案旨在用个体生物等效性代替现行的平均生物等效性。
短句来源
     Bioequivalence of lansoprazole and its metabolites
     兰索拉唑及其代谢产物的生物等效性
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  average bioequivalence
Novel Scaled Average Bioequivalence Limits Based on GMR and Variability Considerations
      
Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products
      
Highly variable drugs pose a problem in bioequivalence assessment because they often fail to meet current regulatory acceptance criteria for average bioequivalence (80-125%).
      
This strategy addresses the shortcomings of average bioequivalence, and, when applied to data sets from bioequivalence studies with four-period replicate crossover designs, turns out to have some satisfactory properties.
      
Bioequivalence of two drug formulations is currently defined by drug regulatory authorities in terms of the mean responses following administration of the test and reference formulations (average bioequivalence).
      
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The purpose of bioequivalence (BE) trial is to show that the test (T) and the reference (R) products can produce similarity bioavailability, and then show therapeutically equivalence. There are three types of bioequivalence, namely, average bioequivalence (ABE), population bioequivalence (PBE) and individual bioequivalence (IBE). The ABE approach focuses only on the comparison of population averages of a BE measure of interest and not on the variances of the measure for the T and R products....

The purpose of bioequivalence (BE) trial is to show that the test (T) and the reference (R) products can produce similarity bioavailability, and then show therapeutically equivalence. There are three types of bioequivalence, namely, average bioequivalence (ABE), population bioequivalence (PBE) and individual bioequivalence (IBE). The ABE approach focuses only on the comparison of population averages of a BE measure of interest and not on the variances of the measure for the T and R products. In contrast, the approaches to establish PBE and IBE include the comparisons of both averages and variances of the measure. The PBE approach assesses total variability of the measure in the population. While the IBE approach assesses within-subject variability for the T and R products, as well as the subject-by-formulation interaction, that is, the variation in the average T and R difference among individuals. In present paper, the principle of the statistical approaches to establish BE, the way to predetermine criterions and BE limits were introduced, and an example were illustrated.

生物等效性试验用于评价试验药 (T)与注册药物 (R)的生物等效性 ,以确定其效应相当。目前生物等效性平均、群体、个体生物等效性三种。平均生物等效性只评价观察指标的平均水平 ,而不考虑个体间的变异 ;而群体生物等效性既考虑了平均水平 ,又考虑了个体间的变异 ;个体生物等效性除考虑平均水平和个体变异 ,还考虑个体与药物间的交互作用。本文介绍了评价三种生物等效性的统计学原理 ,准则 ,等效性界值的确定 ,以及应用中的注意事项。并以实例说明。

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...

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.

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。

 
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