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bioequivalence study
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  生物等效性研究
     Pharmacokinetics and bioequivalence study of amoxycillin and clavulanic acid (7∶ 1)— —a new combination in healthy male volunteers
     阿莫西林与克拉维酸按7∶1配比的药代动力学和生物等效性研究
短句来源
     Bioequivalence Study of 2 Kinds of Zolmitriptan Preparations in Human
     2种佐米曲普坦制剂人体生物等效性研究
短句来源
     Determination of lorazepam in plasma by LC/MS/MS and its application in the bioequivalence study
     液相色谱-串联质谱法测定人血浆中劳拉西泮的浓度及其在生物等效性研究中的应用
短句来源
     Bioequivalence Study of Glipizide Tablets in Healthy Volunteers
     格列吡嗪片健康人体生物等效性研究
短句来源
     Bioequivalence study of three kinds of valsartan preparations in healthy volunteers
     缬沙坦3种制剂的健康人体生物等效性研究
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  生物等效性
     Pharmacokinetics and bioequivalence study of amoxycillin and clavulanic acid (7∶ 1)— —a new combination in healthy male volunteers
     阿莫西林与克拉维酸按7∶1配比的药代动力学和生物等效性研究
短句来源
     Bioequivalence Study of 2 Kinds of Zolmitriptan Preparations in Human
     2种佐米曲普坦制剂人体生物等效性研究
短句来源
     Determination of lorazepam in plasma by LC/MS/MS and its application in the bioequivalence study
     液相色谱-串联质谱法测定人血浆中劳拉西泮的浓度及其在生物等效性研究中的应用
短句来源
     Bioequivalence Study of Glipizide Tablets in Healthy Volunteers
     格列吡嗪片健康人体生物等效性研究
短句来源
     Bioequivalence study of glibenclamide in Xiaotangling Dispersing Tablet in human by LC-MS-MS
     LC-MS-MS法研究消糖灵分散片中格列本脲人体生物等效性
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  “bioequivalence study”译为未确定词的双语例句
     Rapid determination of loxoprofen in human plasma by HPLC-MS and its pharmacokinetics and bioequivalence study
     HPLC-MS法快速测定人血浆中洛索洛芬钠的浓度及其药代动力学研究
短句来源
     Pharmacokinetics and Bioequivalence Study of Simvastation Tablet in Healthy Volunteers by LC-MS/MS Method
     LC-MS/MS法测定人血浆中辛伐他汀的浓度及相对生物利用度
短句来源
     Bioequivalence study of two oral formulations of clarithromycin
     克拉霉素两种制剂的生物等效性研究
短句来源
     The pharmacokinetics and bioequivalence study of quetiapine fumarate tablets
     国产与进口富马酸奎的平片的药动学比较及相对生物利用度
短句来源
     Bioequivalence study of Loratadine tabletes and capsules in healthy volunteers
     氯雷他定的片剂及胶囊在人体内的相对生物利用度
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  bioequivalence study
The articles discussed: (a) the bioequivalence of highly variable drugs, (b) novel metrics for direct comparison of bioequivalence study plasma curves, and (c) the role of a microemulsion vehicle on cutaneous bioequivalence.
      
Bioequivalence Study of Stressed and Nonstressed Hard Gelatin Capsules Using Amoxicillin as a Drug Marker and Gamma Scintigraphy
      
The dissolutionresults of the two formulations were compared with those from anin vivo bioequivalence study undertaken by the central quality controllaboratory of the German pharmacists (ZL).
      
The new specifications require a dose-vasoconstriction response estimation by the use of a Minolta chromameter in a preliminary pilot study to determine the parameters for use in a pivotal bioequivalence study.
      
In order to evaluate the in vitro dissolution and in vivo bioavailability relationship for furosemide, a bioequivalence study was carried out.
      
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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 the conclusion that...

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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