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bioequivalence assessment
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  生物等效性评价
     Bioequivalence assessment of famotidine tablets in 8 healthy volunteers
     法莫替丁片剂在8个健康人体内的生物等效性评价
短句来源
     OBJECTIVE:To evaluate the bioequivalence assessment of theophylline sustained release capsules in healthy volunteers.
     目的 :选择 12名男性健康志愿者 ,进行单剂量口服茶碱缓释胶囊的人体生物等效性评价
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
     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.
     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
短句来源
     Bioequivalence assessment of two lisinopril tablets in healthy volunteers
     赖诺普利片在健康志愿者体内的生物等效性评价
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  “bioequivalence assessment”译为未确定词的双语例句
     Bioequivalence Assessment of Fluconazole Capsules in Human Plasma by HPLC-MS
     HPLC-MS法评价氟康唑胶囊的人体生物等效性
短句来源
     Validation tests indicated that most informative sampling points(ρ1.5,ρ6 for ρmax,ρ1.5,ρ6,ρ12 for AUC0-24) provided accurate estimations of these parameters(Mean prediction error <4%,Mean absolute percentage <8%,standard deviation <10%). Bioequivalence assessment results showed that LSS models provided correct assessment of bioequivalence between two CsA microemulsion(P<0.05).
     5,6ρ,1ρ2估算AUC0t-的准确性较好(平均预测误差<4%、平均绝对误差<8%、标准差<10%),有限采样法评价生物等效性与经典生物等效性研究方法的评价结果无显著性差异(P<0.05)。
短句来源
     For multiple dose administration the peak plasma concentration of SR tablet was 86 14±2 95 ng/ml and the degree of fluctuation (DF) was 140 6±13 5% at steady state. Two one sided tests were performed in bioequivalence assessment.
     多剂量给药达稳态后,本品的峰浓度为8614±295ng/ml,血药浓度波动度为1406±135%。
短句来源
     Bioequivalence Assessment of Domestic Capsule of Meloxicam
     国产美洛昔康胶囊与进口莫比可片的生物等效性研究
短句来源
     Determination of Irbesartan and Hydrochlorothiazide in Human Plasma and Bioequivalence Assessment of the Compound Tablets by Capillary-HPLC
     Cap-HPLC测定人血浆中厄贝沙坦和氢氯噻嗪浓度及其复方制剂的生物等效性研究
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  相似匹配句对
     Bioequivalence Assessment of Valsartan Capsule
     缬沙坦胶囊生物等效性研究
短句来源
     Assessment on Relative Bioavailability and Bioequivalence of Glipizide
     格列吡嗪胶囊的相对生物利用度及其生物等效性评价
短句来源
     risk assessment;
     肾功能; 危险性评估;
短句来源
     On The Assessment of ERP
     浅谈ERP的评估
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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  bioequivalence assessment
clinical trial methods for bioequivalence assessment of two miconazole nitrate vaginal cream, 2% products.
      
Clinicial Efficacy Methods for Bioequivalence Assessment of Miconazole Nitrate Vaginal
      
Highly variable drugs pose a problem in bioequivalence assessment because they often fail to meet current regulatory acceptance criteria for average bioequivalence (80-125%).
      
Bioequivalence assessment of etoposide phosphate and etoposide using pharmacodynamic and traditional pharmacokinetic parameters
      
Sample size determination for bioequivalence assessment using a multiplicative model
      
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In this paper the primary theory and formularies of Bayesian method were introduced.After intramuscular injection of two formulations of diclofenac sodium (solution 75mg/3ml and lyophilized 75mg/+1ml) in twelve healthy volunteers,the plasma concentration was determined by HPLC.The pharmacokinetic parameters AUC、T max and C max were calculted.The experimental procedure and bioequivalence assessment were described with Bayesian method.

本文介绍了贝叶斯法的基本原理及有关公式。以双氯芬酸钠普通注射剂和冻干注射剂为实验药物,给予12名健康受试者分别肌内注射两制剂一次剂量(75mg)后,于高效液相色谱中测定血浆药物浓度,计算药物动力学参数AUC、Cmax和Tmax值。以这3个动力学参数为基本数据,详细描述了应用贝叶斯法评价制剂生物等效性的操作方法

The relative bioavailability of famotidine sustained release (SR) tablets was studied in 16 healthy male volunteers. Famotidine plasma concentration was determined by HPLC method, and the plasma concentration time data were processed with the method provided by USP XXIII. For single dose administration the peak plasma concentration occurring at 8 13±0 34 h was 69 52±3 00 ng/ml and the relative bioavailability was 112 4±8 6%. For multiple dose administration the peak plasma concentration of SR tablet...

The relative bioavailability of famotidine sustained release (SR) tablets was studied in 16 healthy male volunteers. Famotidine plasma concentration was determined by HPLC method, and the plasma concentration time data were processed with the method provided by USP XXIII. For single dose administration the peak plasma concentration occurring at 8 13±0 34 h was 69 52±3 00 ng/ml and the relative bioavailability was 112 4±8 6%. For multiple dose administration the peak plasma concentration of SR tablet was 86 14±2 95 ng/ml and the degree of fluctuation (DF) was 140 6±13 5% at steady state. Two one sided tests were performed in bioequivalence assessment. The results showed that the sustained release tablets were basically bioequivalent to the immediate release (IR) tablets on sale.

对法莫替丁缓释片在16名健康志愿者体内的生物利用度进行了研究。以高效液相色谱法测定血药浓度,依据美国药典23版中关于生物等效性指南的有关要求处理数据。结果表明:单剂量给药,本品的达峰时间为813±034h,峰浓度为6952±300ng/ml,相对生物利用度为1124±86%;多剂量给药达稳态后,本品的峰浓度为8614±295ng/ml,血药浓度波动度为1406±135%。对AUC进行双单侧检验的结果证明本品与市售普通片生物等效。

OBJECTIVE:To evaluate the bioequivalence assessment of single dose ambroxol hydrochloride sustained release capsules in healthy volunteers.METHODS:A reversed phase high performance liquid chromatography (RP HPLC) method was established for the determination of ambroxol in plasma after a single oral dose of 75 mg domestic ambroxol hydrochloride sustained release capsules and imported ambroxol hydrochloride sustained release capsules in a randomized crossover design.The detector was operated at UV 245...

OBJECTIVE:To evaluate the bioequivalence assessment of single dose ambroxol hydrochloride sustained release capsules in healthy volunteers.METHODS:A reversed phase high performance liquid chromatography (RP HPLC) method was established for the determination of ambroxol in plasma after a single oral dose of 75 mg domestic ambroxol hydrochloride sustained release capsules and imported ambroxol hydrochloride sustained release capsules in a randomized crossover design.The detector was operated at UV 245 nm.RESULTS:The dynamic course of ambroxol plasma concentrations conformed to a two compartment open model with a 3P87 program and the main pharmacokinetic parameters after a single oral dose of 75 mg domestic sustained release capsules and imported sustained release capsules were as follows: C max were ( 176.5 ± 38.9 )ng·ml -1 and ( 174.9 ± 33.0 )ng·ml -1 , t max were ( 3.8 ± 0.6 )h and ( 4.1 ± 0.5 )h, MRT were ( 16.2 ± 2.8 )h and ( 16.0 ± 1.6 )h, t 1/2 were ( 11.4 ± 2.7 )h and ( 11.1 ± 1.8 )h, AUC 0-36 were ( 1740.4 ± 382.1 )ng·h·ml -1 and ( 1738.7 ± 326.3 )ng·h·ml -1 ,respectively.CONCLUSIONS:The relative bioavailability of domestic ambroxol hydrochloride sustained release capsules was ( 99.7 ± 7.0 )%.The results of statistical analysis for C max , AUC 0-36 and AUC 0-∞ showed that domestic sustained release capsules and imported sustained release capsules were bioequivalent.

目的 :选择 12名男性健康志愿者 ,进行单剂量口服盐酸氨溴索缓释胶囊的人体生物等效性评价。方法 :采用反相高效液相色谱法 ,以紫外 2 4 5nm为检测波长 ,测定了单剂量口服 75mg国产盐酸氨溴索缓释胶囊受试药品和进口盐酸氨溴索缓释胶囊参比药品在健康人体内的氨溴索浓度。结果 :盐酸氨溴索缓释胶囊的体内动态过程呈一级吸收的二房室开放模型 ,国产受试药品和进口参比药品的Cmax分别为 (176.5± 3 8.9)ng·ml-1和 (174 .9± 3 3 .0 )ng·ml-1,tmax分别为 (3 .8± 0 .6)h和 (4 .1± 0 .5 )h ,MRT分别为 (16.2± 2 .8)h和 (16.0± 1.6)h ,T1/ 2 分别为 (11.4± 2 .7)h和 (11.1± 1.8)h ,AUC0 -36 分别为 (174 0 .4± 3 82 .1)ng·h·ml-1和 (173 8.7± 3 2 6.3 )ng·h·ml-1。结论 :以体内氨溴索AUC0 -36 数值表征的国产盐酸氨溴索缓释胶囊的相对生物利用度为 (99.7± 7.0 ) % ;选择Cmax、AUC0 -36 和AUC0 ...

目的 :选择 12名男性健康志愿者 ,进行单剂量口服盐酸氨溴索缓释胶囊的人体生物等效性评价。方法 :采用反相高效液相色谱法 ,以紫外 2 4 5nm为检测波长 ,测定了单剂量口服 75mg国产盐酸氨溴索缓释胶囊受试药品和进口盐酸氨溴索缓释胶囊参比药品在健康人体内的氨溴索浓度。结果 :盐酸氨溴索缓释胶囊的体内动态过程呈一级吸收的二房室开放模型 ,国产受试药品和进口参比药品的Cmax分别为 (176.5± 3 8.9)ng·ml-1和 (174 .9± 3 3 .0 )ng·ml-1,tmax分别为 (3 .8± 0 .6)h和 (4 .1± 0 .5 )h ,MRT分别为 (16.2± 2 .8)h和 (16.0± 1.6)h ,T1/ 2 分别为 (11.4± 2 .7)h和 (11.1± 1.8)h ,AUC0 -36 分别为 (174 0 .4± 3 82 .1)ng·h·ml-1和 (173 8.7± 3 2 6.3 )ng·h·ml-1。结论 :以体内氨溴索AUC0 -36 数值表征的国产盐酸氨溴索缓释胶囊的相对生物利用度为 (99.7± 7.0 ) % ;选择Cmax、AUC0 -36 和AUC0 -∞ 进行 3因素方差分析与双单侧t检验 ,结果表明国产盐酸氨溴索缓释胶囊和进口盐酸氨溴索缓释胶囊两种制剂具有生物等效性。

 
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