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bioequivalence studies
相关语句
  生物等效性试验
     STATISTICAL DESIGN AND ANALYSIS OF BIOEQUIVALENCE STUDIES BY EXAMPLE
     借助实例介绍生物等效性试验的统计设计与分析
短句来源
     Thinking on ethical principle in bioequivalence studies
     人体生物等效性试验设计的伦理思考
短句来源
     However there exist a lot of problems in present bioequivalence studies, they haveadverse impact on bioequivalence decision making.
     但目前的生物等效性试验还存在着不少问题,这些问题直接影响对生物等效性结果的判断。
短句来源
     This paper provides principal concepts about statistical design and analysis of bioequivalence studies by real example. The differences between the 22 Cross_over design and the design for t_test are discussed.
     本文通过实例介绍生物等效性试验的统计设计和分析的基本概念,尤其着重介绍2×2交叉设计与作t检验的设计之间的区别。
短句来源
  “bioequivalence studies”译为未确定词的双语例句
     Pharmacokinetic and bioequivalence studies of simvastatin tablet in healthy volunteers by LC-MS/MS
     LC-MS/MS法研究辛伐他汀片在健康人体内的药代动力学及生物等效性
短句来源
     The significance,feasibility and methodology of bioequivalence studies on recombinant protein or peptide
     重组蛋白多肽药物生物等效性研究的必要性、可行性和方法学
短句来源
     It is peculiar for the normality test of bioequivalence studies data.
     本文对生物等效性研究数据的正态性检验用到峰态和偏态统计量,未见国内外有类似报道。
短句来源
     Bioequivalence studies of compound isosorbide-mononitrate sustained release tablets in healthy volunteers
     复方单硝酸异山梨醇酯缓释片人体生物等效性研究
短句来源
     Pharmacokinetics and Bioequivalence Studies of Tegaserod in Healthy Volunteers
     替加色罗人体药代动力学试验及其制剂生物等效性评价
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  相似匹配句对
     Studies on N.
     对北冰洋西部N.
短句来源
     Studies on the bioequivalence of adefovir dipivoxil in dogs
     阿德福韦酯生物等效性实验研究
短句来源
     Thinking on ethical principle in bioequivalence studies
     人体生物等效性试验设计的伦理思考
短句来源
     STUDIES ON APINI
     蜜蜂族Apini的研究
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  bioequivalence studies
In bioequivalence studies, the trapezoidal rule on the sampled time points is often used to estimate the area under the plasma concentration-time curve, a quantity of principal interest.
      
Optimal sampling times in bioequivalence studies using a simulated annealing algorithm
      
Characterization of the Human Upper Gastrointestinal Contents Under Conditions Simulating Bioavailability/Bioequivalence Studies
      
We therefore applied those principles (based on estimates of intrinsic clearance after oral administration of the parent drug) to four bioequivalence studies from our archives, in which the parent drug and at least one metabolite were monitored.
      
A more promising area of exploration is recommendations based on simulated bioequivalence studies for which the "correct" answers are known, given the assumptions.
      
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This paper provides principal concepts about statistical design and analysis of bioequivalence studies by real example. The differences between the 22 Cross_over design and the design for t_test are discussed. For the outcomes of bioequivalence studies, several analytical methods are introduced: ANOVA, two one_sided t_test, non_parametric method.Different results of its responses data,Non_logarithm_transformed or logarithm_transformed, are provided. An equation and SAS program for sample size of...

This paper provides principal concepts about statistical design and analysis of bioequivalence studies by real example. The differences between the 22 Cross_over design and the design for t_test are discussed. For the outcomes of bioequivalence studies, several analytical methods are introduced: ANOVA, two one_sided t_test, non_parametric method.Different results of its responses data,Non_logarithm_transformed or logarithm_transformed, are provided. An equation and SAS program for sample size of 22 Cross_over design are given in the paper. A real example is analyzed by BASIC and SAS programs, which outputs are consistent and interpreted deeply. It is peculiar for the normality test of bioequivalence studies data.

本文通过实例介绍生物等效性试验的统计设计和分析的基本概念,尤其着重介绍2×2交叉设计与作t检验的设计之间的区别。对这类试验所得数据结果介绍了各种分析方法:方差分析,双单侧t检验,非参数方法,给出响应数据不经过对数变换和经过对数变换所得不同结果。给出了用SAS软件计算做交叉设计所需样本大小的程序。实际例子用BASIC和SAS程序加以分析,所得结果是一致的,还对输出结果加以深入说明。本文对生物等效性研究数据的正态性检验用到峰态和偏态统计量,未见国内外有类似报道。

Objective:To establish a high performance capillary zone electrophoresis method for determining bambuterol and terbutalin in human plasma.Methods:A SPE(solid phase extraction)plus C 18 column was used to extract bambuterol and terbutalin.A short buffer plug was introduced into the inlet of the capillary and then the sample solution was injected with an electrokinetic mode to enhance sensitivity.The running buffer was 80 mmol·L -1 phosphate buffer(NaH 2PO 4 solution,adjust pH=3.15 with H 3PO 4),running...

Objective:To establish a high performance capillary zone electrophoresis method for determining bambuterol and terbutalin in human plasma.Methods:A SPE(solid phase extraction)plus C 18 column was used to extract bambuterol and terbutalin.A short buffer plug was introduced into the inlet of the capillary and then the sample solution was injected with an electrokinetic mode to enhance sensitivity.The running buffer was 80 mmol·L -1 phosphate buffer(NaH 2PO 4 solution,adjust pH=3.15 with H 3PO 4),running voltage was 25 kV.Results:With the propranolol as internal standard,bambuterol and terbutalin were separated well and without interference from human plasma.For bambuterol the linear range was 16~0 125 μg·L -1 .For terbutalin the linear range was 40~0 3125 μ·L -1 .The intra-day precision was 11%,the inter-day precision was 12%.Conclusion:This method is very suitable for clinical pharmacokinetic and bioequivalence study.

目的 :建立测定人血浆中班布特罗及其代谢物特布他林血药浓度的高效毛细管电泳方法。方法 :运行缓冲液为 80mmol·L-1磷酸二氢钠缓冲液 (用磷酸调 pH =3 15 ) ;电压进样 :10kV ,10s ;运行电压 2 5kV ,检测波长为 2 0 0nm ,采用固相萃取的方法进行班布特罗及其代谢物特布他林的提取。结果 :班布特罗及其特布他林峰形良好 ,且血浆组分无干扰峰 ,采用普萘洛尔为内标 ,班布特罗测定的线性范围为 16~ 0 12 5 μg·L-1,特布他林测定的线性范围为 40~ 0 312 5 μg·L-1。本法的日内RSD小于 11% ,日间RSD小于 12 %。结论 :本法是一种简单、灵敏的高效毛细管电泳柱上富集方法 ,适用于药代动力学及其生物等效性的研究

In the first part of this paper,the bioequivalence studies on recombinant protein or peptide in abroad and examples were briefly reviewed,and the significance of bioequivalence studies at different stage of new drug development for pharmaceutical companies and regulatory agencies were emphasized.In the second part of this paper,the experiences,methodology,and results of our laboratory on evaluation of bioequivalence on recombinant protein or peptide were introduced in detail.We emphasized in...

In the first part of this paper,the bioequivalence studies on recombinant protein or peptide in abroad and examples were briefly reviewed,and the significance of bioequivalence studies at different stage of new drug development for pharmaceutical companies and regulatory agencies were emphasized.In the second part of this paper,the experiences,methodology,and results of our laboratory on evaluation of bioequivalence on recombinant protein or peptide were introduced in detail.We emphasized in the conclusion that the bioequivalence study for chemical drugs is as important as for biological products.The commonly used method for determination of protein or peptide in plasma is enzyme linked immunosorbent assay(ELISA) method,and bioassay is also necessary sometimes.

首先简单综述了国外对重组蛋白或多肽生物等效性研究的概况和实例。重点讨论了药品生产厂家和管理当局对药物开发不同阶段生物等效性评价必要性的认识 ,介绍了生物等效性评价的方法和结果。然后详细介绍了本实验室进行重组蛋白或多肽药物生物等效性研究的经验、方法和结果。最后强调了生物等效性研究对于化学药物和生物制品的同等重要性。重组蛋白或多肽药物浓度测定常用方法是酶联免疫吸附测定 (ELISA) ,必要时也可用生物检定法测定活性浓度

 
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