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individual bioequivalence
相关语句
  个体生物等效性
     Assessment of Individual Bioequivalence in 3-sequence 3-period Crossover Designs Using Generalized P-value
     3×3设计中个体生物等效性评价的广义P-值法
短句来源
     Discussion of Samples in Individual Bioequivalence
     关于个体生物等效性评价中样本容量的讨论
短句来源
     The generalizedp-value approach may be an effective method for assessing population bioequivalenceand individual bioequivalence
     用广义 P-值方法来评价群体生物等效性和个体生物等效性是另一种有效的方法。
短句来源
     AIM:To compare efficacy of two designs and three test approaches in individual bioequivalence and estimate sample size.
     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。
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
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  相似匹配句对
     Discussion of Samples in Individual Bioequivalence
     关于个体生物等效性评价中样本容量的讨论
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
     individual spirit;
     个体精神;
短句来源
     On Individual Ownership
     对“重新建立个人所有制”的辨析
短句来源
     The twopreparations of erythromycin are of bioequivalence.
     结论:两种红霉素制剂具有生物等效性。
短句来源
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  individual bioequivalence
Oneof these variances in the individual bioequivalence criterion measuressubject-by-formulation interaction, the extent to which thetest-reference difference varies from person to person.
      
The FDA has proposed replacing the current averagebioequivalence criterion with population and individual bioequivalence criteriathat consider variances in addition to the difference of averages.
      
To determine properties of the estimated variance component for the subject-by-formulation interaction (σ2D) in investigations of individual bioequivalence (IBE), and 2.
      
Subject-by-Formulation Interaction in Determinations of Individual Bioequivalence: Bias and Prevalence
      
Individual Bioequivalence: Attractive in Principle, Difficult in Practice
      
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Objective: To clarify the current research status and the future direction of the bioequivalence test and clinical equivalence. Methods: The principle of the equivalence test, new progresses of bioequivalence including population/individual bioequivalence and statistical tests for multivariate bioequivalence, some important issues concerning the therapeutic equivalence including equivalence margin, primary endpoint of trials, and some other problems to be solved were introduced in the analysis. Conclusion:...

Objective: To clarify the current research status and the future direction of the bioequivalence test and clinical equivalence. Methods: The principle of the equivalence test, new progresses of bioequivalence including population/individual bioequivalence and statistical tests for multivariate bioequivalence, some important issues concerning the therapeutic equivalence including equivalence margin, primary endpoint of trials, and some other problems to be solved were introduced in the analysis. Conclusion: The basic method of the equivalence test has been accepted; however, there are still some issues to be solved in application. It is important to facilitate the reasonable employment and development of equivalence.

目的 :阐明生物等效性与临床等效性的研究现状及发展方向。方法 :介绍新药等效性评价方法的原理 ,生物等效性分析方法的新进展包括总体或 (和 )个体生物等效性和多变量生物等效性检验的方法 ,以及临床等效性中等效界值、目标参数及有待解决的问题 ,并结合实例进行论述。结论 :等效性评价的基本方法已得到推广使用 ,但在应用上还存在很大的可塑性 ,不利于新药审评标准的把握 ,应加强等效性评价方法的正确应用与发展。

In this presentation,the author would summarize something about the bioequivalence's evaluation,such as the history of creation;the evaluation method; the design of the experiment method and the necessity of the evaluation of the population bioequivalence and the individual bioequivalence.

本文概括介绍了生物等效性评价形成的历史、评价方法和试验设计等方面的内容,并提出对群体生物等效性和个体生物等效性评价的必要性。

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 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。

 
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