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   population bioequivalence 的翻译结果: 查询用时:0.129秒
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population bioequivalence
相关语句
  总体生物等效性
     The statistical methods of individual bioequivalence and population bioequivalence are studied. The procedure of individual bioequivalence is given.
     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.
短句来源
  群体生物等效性
     In chapter 4,we will introduce the generalized test function and thegeneralized p-value into the assessment of population bioequivalence and individualbioequivalence,and proof that generalized p-value is continuous.
     在第四章,我们引入广义检验函数和广义 P-值来评价群体生物等效性和个体生物等效性,并证明广义 P-值法在评价群体生物等效性和个体生物等效性的连续性。
短句来源
  相似匹配句对
     In small population?
     大群体中则稳定下降、波动较小。
短句来源
     ⑤population;
     ⑤人口的变化;
短句来源
     The statistical methods of individual bioequivalence and population bioequivalence are studied. The procedure of individual bioequivalence is given.
     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.
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
     Bioequivalence of lansoprazole and its metabolites
     兰索拉唑及其代谢产物的生物等效性
短句来源
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  population bioequivalence
This article, therefore, introduces the proposal to combine the chi-square ratio test with a test for impactor-sized mass based on Population Bioequivalence and describes methods for evaluating discrimination capabilities of the combined test.
      
These measures provide bases for assessing conditions under which average bioequivalence is not sufficient to ensure switchability and prescribability, and hence for which a procedure for individual or population bioequivalence is required.
      
For the changes of formulations prior to the NDA submission, the draft guidance asks for population bioequivalence.
      


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....

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。

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.

 
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