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bioequivalence test
相关语句
  生物等效性检验
     The two parameters were of not significant difference (P<0.05) via bioequivalence test.
     上述两参数P>0.05生物等效性检验)。
短句来源
     tmax was 3.9 1 l. 6 h (po ivermectin tablet 12mg) and 4.1 1 l. 2 h (Po MECTIZAN 12mg), and was significant difference (P<0.05; bioequivalence test).
     tmax分别为3.9±1.6h和4.1±1.2h, P>0.05(生物等效性检验)。
短句来源
     The method to analyze 2×2 crossover designed bioequivalence test by EXCEL form was introduced.
     介绍用电子表格 (Excel)编制双交叉设计的生物等效性检验分析表格的方法。
短句来源
     METHODS The bioequivalence test of cefixime done by the first affiliated of china Medical University was analyzed by the traditional method and statistics similarity method.
     方法用中国医科大学附属第一医院承担的头孢克肟生物等效性试验作为范例分析,计算了传统生物等效性检验和数理相似性检验。
短句来源
     Microsoft Excel in Analysis 2×2 Crossover Designed Bioequivalence Test
     用电子表格进行双交叉设计的生物等效性检验分析
短句来源
更多       
  等效性检验
     The Determination of β in Bioequivalence Test by Monte Carlo Simulation
     模拟验证等效性检验中β的单、双侧取值
短句来源
     Objective To study the sample size calculation of bioequivalence test in clinical trial.
     目的研究临床试验中等效性检验的样本量的计算问题。
短句来源
     Conclusion β should be two-sided when θ is zero in calculation of sample size of bioequivalence test,otherwise,β is one-sided.
     结论在等效性检验的样本量估算中,当θ为0时,β取双侧; 当θ不等于0时,β取单侧。
短句来源
  生物等效性试验
     THE APPLICATION OF MIC RELATED PARAMETERS IN THE BIOEQUIVALENCE TEST OFCEFADROXIL GRANULES
     MIC关联的参数在头孢羟氨苄颗粒剂生物等效性试验中的应用
短句来源
     METHODS The bioequivalence test of cefixime done by the first affiliated of china Medical University was analyzed by the traditional method and statistics similarity method.
     方法用中国医科大学附属第一医院承担的头孢克肟生物等效性试验作为范例分析,计算了传统生物等效性检验和数理相似性检验。
短句来源
  “bioequivalence test”译为未确定词的双语例句
     Statistical analysis (paired t test) showed no significant difference between test drug and reference drug for Tmax, Cmax and AUC (P>0. 05). The bioequivalence test showed no significant difference between two preparations for Tmax, Cmax and AUC (P>0. 05), too. CONCLUSION: The pharmacokinetics of captopril test drug and reference drug were similar and the result of statistics showed that the two preparations were
     对药动学参数AUC、Cmax进行单因素方差分析及双单侧t检验,Tmax结果进行非参数法检验,结果表明受试制剂和参比制剂药动学参数没有显著性差异,具有生物等效性。
短句来源
     Using cefadroxil capsules as reference formulation,the bioequivalence test of cefadroxil granules was conducted on ten healthy volunteers.
     本项实验在10名志愿受试者身上采用交叉设计法,以头孢羟氨苄胶囊为标准参比制剂,采用HPLC法对头孢羟氨苄颗粒剂进行了相对生物利用度试验。
短句来源
     The plasma concentrations were determined by HPLC. Pharmacokinetic parameters and compartment model were obtained using 3P97.The bioequivalence test were studied on lnAUC (0-t), lnC (max) and t (max) by two one-side t test.
     用高效液相色谱法测定血药浓度,用3P97软件计算药代动力学参数,考察其生物等效性。
短句来源
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  bioequivalence test
The probability of failing the bioequivalence test is shown to dramatically decrease upon multiple dosing due to the changes (range and shift) in the confidence interval.
      
When each subject in two comparison groups has a fixed number of repeated measurements, this paper develops an asymptotic procedure to calculate the number of subjects per group required to achieve a given power for an α-level bioequivalence test.
      
Sample Size Determination for Repeated Measurements in Bioequivalence Test
      
The crucial problem is, that for approval of any new formulation of a known (generic) drug a bioequivalence test has to be performed.
      


Using cefadroxil capsules as reference formulation,the bioequivalence test of cefadroxil granules was conducted on ten healthy volunteers.In addition to Cmax,Tmax and AUC0~∞,the time point that the drug concentration in plasma exceeded the minimal inhibitory concentration(MIC)of cefadroxil(To),the time that the drug concentration stayed above the MIC(Te),and the AUC abovethe MIC(AUCeff)were also used as parameters to evaluate the bioequivalence.The results showed that two formulations were bioequivalent...

Using cefadroxil capsules as reference formulation,the bioequivalence test of cefadroxil granules was conducted on ten healthy volunteers.In addition to Cmax,Tmax and AUC0~∞,the time point that the drug concentration in plasma exceeded the minimal inhibitory concentration(MIC)of cefadroxil(To),the time that the drug concentration stayed above the MIC(Te),and the AUC abovethe MIC(AUCeff)were also used as parameters to evaluate the bioequivalence.The results showed that two formulations were bioequivalent with three traditional parameters. And with three selected MIC, the AUCeff and Te of the two formulations supported bioequivalence conclution, and To indicated faster reachig of MIC level by granules than capsules.

本项实验在10名志愿受试者身上采用交叉设计法,以头孢羟氨苄胶囊为标准参比制剂,采用HPLC法对头孢羟氨苄颗粒剂进行了相对生物利用度试验。在常用生物等效性指标Cmax,Tmax,AuC0 ̄∞的基础上引入了MIC(最小抑菌浓度)以上的有效AUC(AUCeff)达到MIC的时间(To)和MIC以上浓度的持续时间(Te)。对这些参数进行生物等效性的评价的意义进行了探讨。传统的评价方法显示两制剂生物等效。AUCeff和Te的结果支持等效结论,而To的结果显示颗粒剂比胶囊早达到MIC。

With the data from one bioequivalence test.two one-sided t-test was used as statistics method.And the calculation method was introduced.

通过生物利用度试验的具体实例,介绍双单测t检验的具体计算方法。

OBJECTIVE: To observe of pharmacokinetics of orally taking ivermectin 6, 12, 18 mg and bioavailability afterpo (Per os) ivermechn tablet 12 mg. METHODS: Three groups of volunteers (8 subjects in each group) orally took ivermertin 6, 12, 18mg. Two kinds of ivermectin tablet were orally administered by randomized-cross and auto-pair method within 2 weeks in the group of po 12mg. Plasma and urine concentration of ivermectin was detected by HPLC method. RESULTS: AUCo- was in proportion to dose of po ivermecitn 6-12mg...

OBJECTIVE: To observe of pharmacokinetics of orally taking ivermectin 6, 12, 18 mg and bioavailability afterpo (Per os) ivermechn tablet 12 mg. METHODS: Three groups of volunteers (8 subjects in each group) orally took ivermertin 6, 12, 18mg. Two kinds of ivermectin tablet were orally administered by randomized-cross and auto-pair method within 2 weeks in the group of po 12mg. Plasma and urine concentration of ivermectin was detected by HPLC method. RESULTS: AUCo- was in proportion to dose of po ivermecitn 6-12mg (418 1 288ug.h.L-1 in 6mg group, 813 1 156ug.h.L-1 in 12 mg group), but AUCo- (980 f 474 ug.h.L-1) did not increase when dosage of po ivermectin reached 18mg compared with po 12mg. C-T curves of the 3 dosages of po ivermectin accorded with one-compent linear elimination model. t1/2ke of po ivermectin 6,12 and 18mg was 11.1 1 4.6, 21.1 1 7.0, 16.7 1 6.6 h, respectively. AUCo-72h was 791.4 1 243.ins.h.L-1 the ivermectin tablet 12mg) and 734.6 1 202.9 ug.h.L-1 (po MECTIZAN 12mg), Cmax was 31.7 1 5.6 (po ivermectin tablet 12 mg) and 31.1 1 4.7 ig.L-1(po MECTIZAN 12mg). Relative bioavailability was 102 1 19%. The two parameters were of not significant difference (P<0.05) via bioequivalence test. tmax was 3.9 1 l.6 h (po ivermectin tablet 12mg) and 4.1 1 l.2 h (Po MECTIZAN 12mg), and was significant difference (P<0.05; bioequivalence test). CONCLUSIONS: The data showed basically accordance with linear elimination pharmacoklnetics after po ivermectin 6-18mg, but the Phenomenon of absorphon saturation appeared when the dosage of po ivermectin 18mg. AUC and Cma were bioequivalent after po two sorts of ivermectin tablet. Prototype of ivermetin did not exist in urine sample following po ivermectin.

目的:观察口服伊维菌素片后的人体药动学特征及口服伊维菌素片12mg的生物利用度。方法:用HPLC法检测3组(每组8人)健康志愿者分别口服伊维菌素片 6,12,18 mg(12 mg组随机交叉自身对照分别在2周间隔时间口服两种伊维菌素片)后血药和尿药浓度。结果:口服伊维菌素片6mg和12mg,AUCo-值分别为 418 ± 288,813 ± 156 μg·h·L-1增加基本与剂量比成比例,口服 18 mg,AUC0-值为 980 ± 4749·h·L-1不再增加。3组的 t1/2ke分别为 11·1± 4.6、 21·1±7.0、16.7±6.6h。经拟合3组的药-时曲线符合一房室线性消除动力学模型。分别单次口服12mg国产品进口伊维菌素片, AUC0-72h分别为791.4 ± 243.1和734.6±202.9μg·hL-1,Cmax分别为31.7±5.6和31.1±4.7μg·L-1。相对生物利用度为102±19%。上述两参数P>0.05生物等效性检验)。tmax分别为3.9±1.6h和4.1±1.2h, P>0.05(生物等效性检验)。结论:口服伊维菌素片6-18mg符合一级消除动力学。但剂量达 18...

目的:观察口服伊维菌素片后的人体药动学特征及口服伊维菌素片12mg的生物利用度。方法:用HPLC法检测3组(每组8人)健康志愿者分别口服伊维菌素片 6,12,18 mg(12 mg组随机交叉自身对照分别在2周间隔时间口服两种伊维菌素片)后血药和尿药浓度。结果:口服伊维菌素片6mg和12mg,AUCo-值分别为 418 ± 288,813 ± 156 μg·h·L-1增加基本与剂量比成比例,口服 18 mg,AUC0-值为 980 ± 4749·h·L-1不再增加。3组的 t1/2ke分别为 11·1± 4.6、 21·1±7.0、16.7±6.6h。经拟合3组的药-时曲线符合一房室线性消除动力学模型。分别单次口服12mg国产品进口伊维菌素片, AUC0-72h分别为791.4 ± 243.1和734.6±202.9μg·hL-1,Cmax分别为31.7±5.6和31.1±4.7μg·L-1。相对生物利用度为102±19%。上述两参数P>0.05生物等效性检验)。tmax分别为3.9±1.6h和4.1±1.2h, P>0.05(生物等效性检验)。结论:口服伊维菌素片6-18mg符合一级消除动力学。但剂量达 18mg时有吸收饱和现象。

 
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