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   bioequivalence 在 医药卫生方针政策与法律法规研究 分类中 的翻译结果: 查询用时:0.129秒
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bioequivalence
相关语句
  生物等效性
    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
    Bioequivalence Assessment with Missing Data Using MCMC
    有缺失数据的生物等效性评价的MCMC方法
短句来源
    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
    Statistical Approaches for Assessment of Bioavailability and Bioequivalence
    生物利用度与生物等效性评价的统计方法
短句来源
    Bioequivalence investigation is very important to ensure the bioequivalencebetween generic drug and innovator drug and make sure they have the same therapeuticefficacy and safety. It plays an important role in the development and evaluation of newdrug.
    生物等效性研究对于保证受试药(仿制药)与参比药(标准药)生物等效,具有相同的有效性和安全性,保证受试药品的质量是极其重要的药物研制环节,在新药开发和新药评价过程中发挥着非常重要的作用。
短句来源
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  “bioequivalence”译为未确定词的双语例句
    The Determination of β in Bioequivalence Test by Monte Carlo Simulation
    模拟验证等效性检验中β的单、双侧取值
短句来源
    Two one-sided t test and confidence interval are the main methods which analysisthe bioequivalence of two formulation in two crossover trial for bioavailability.
    生物利用度试验的等效性研究中,对双交叉设计试验,已有成熟的等效性分析的统计方法。
短句来源
  相似匹配句对
    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
    Statistical Approaches for Assessment of Bioavailability and Bioequivalence
    生物利用度与生物等效性评价的统计方法
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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With the data from one bioequivalence test.two one-sided t-test was used as statistics method.And the calculation method was introduced.

通过生物利用度试验的具体实例,介绍双单测t检验的具体计算方法。

Objective To provide a useful statistical method for bioequivalence assessment with missing data.Methods Constructing random effect model for the data of crossover design and using the software WinBUGS, bioequivalence assessment based on bayesian theory was made through MCMC.Results For complete data and missing data, MCMC calculated the posterior probabilities for each situations. Bioequivalence assessment was done and the result was the same as the related report.Conclusion MCMC is a effective...

Objective To provide a useful statistical method for bioequivalence assessment with missing data.Methods Constructing random effect model for the data of crossover design and using the software WinBUGS, bioequivalence assessment based on bayesian theory was made through MCMC.Results For complete data and missing data, MCMC calculated the posterior probabilities for each situations. Bioequivalence assessment was done and the result was the same as the related report.Conclusion MCMC is a effective solution for bayesian method in bioequivalence assessment with missing data.

目的 为有缺失数据的生物等效性评价资料的处理提供一种实用的统计方法。方法 构建两阶段交叉设计的随机效应模型 ,使用WinBUGS软件由MCMC方法给出两种药物的基于贝叶斯理论的生物等效性评价。结果 对完整数据和有缺失数据的情形 ,MCMC方法分别计算出了待评价指标落于等效区间的后验概率从而做出了生物等效性评价 ,结论与文献报道一致。结论 MCMC方法可以方便地给出生物等效性评价的贝叶斯推断结果 ,能有效处理有缺失数据的试验资料并提供缺失数据的估计值 (或分布 )。

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...

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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