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bioequivalence evaluation
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  生物等效性评价
     Bioequivalence evaluation of domestic ambroxol hydrochloride tablets in healthy subjects
     国产盐酸氨溴索片在健康人体内的生物等效性评价
短句来源
     Progress in Methodology of Bioequivalence Evaluation
     生物等效性评价方法的进展
短句来源
     Bioequivalence evaluation on domestic and imported nimodipine tablets
     国产和进口尼莫地平片的生物等效性评价
短句来源
     The pharmacokinetics study and bioequivalence evaluation of the VPA sustained-release tablet in dogs were made.
     进行了家犬体内VPA缓释片药物动力学研究和生物等效性评价
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     Methods A single oral dose 200 mg of two formulations of fleroxacin was given to 20 healthy volunteers in an open randomized cross-over study. Plasma levels of fleroxacin were determined by HPLC-UV me-thod. The pharmacokinetic parameters and the bioequivalence evaluation were obtained by 3P97 software.
     方法用随机分组自身对照方法,20例健康男性志愿者单次口服氟罗沙星参比和受试制剂200mg后,用高效液相色谱-紫外法测定血浆中氟罗沙星浓度,用3P97软件进行药代动力学参数的计算及生物等效性评价
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  “bioequivalence evaluation”译为未确定词的双语例句
     Bioequivalence evaluation of two salbutamol MDIs in asthmatic patients by pharmacokinetic and pharmacodynamic methods
     药动学和药效学方法考察沙丁胺醇气雾剂的生物等效性
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     Bioequivalence evaluation of zolpidem tartrate tablets
     国产酒石酸唑吡坦的生物利用度和生物等效性研究
短句来源
     Bioequivalence evaluation of two brands of fluconazole capsules in healthy volunteers
     氟康唑胶囊的人体生物等效性研究
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     Bioequivalence evaluation of secnidazole tablets in healthy male volunteers
     塞克硝唑片剂健康人体生物等效性研究(英文)
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  相似匹配句对
     On Evaluation
     浅议评估的定义
短句来源
     Progress in Methodology of Bioequivalence Evaluation
     生物等效性评价方法的进展
短句来源
     On Evaluation
     论“评价”
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     Some Issues in Bioequivalence Evaluation
     生物等效性评价中的若干问题
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  bioequivalence evaluation
Simulations were conducted to address the question of whether metabolite data are required for bioequivalence evaluation of immediate release formulations with drugs exhibiting linear pharmacokinetics and first-pass effect.
      
However, a clear difference with respect to the outcome of bioequivalence evaluation arises depending upon the utilization of Cmax values for the parent drug and metabolite.
      
Some implications for the kinetic/dynamic relationship or modeling, in the clinical use, and in the bioequivalence evaluation of dosage forms are discussed.
      
Pharmacokinetics and bioequivalence evaluation of three commercial tablet formulations of mefloquine when given in combination w
      
Pharmacokinetic and bioequivalence evaluation of two generic formulations of oral artesunate
      
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A review of in the literature about bioequivalence evaluation in the past decade.Quite a few new opinions and suggestions were made. However, the new evaluation methodcan not be carried out until it is verified and approved by theory and sufficient practice.

检索近年来有关生物等效性评价理论的文献,发现有不少评价生物等效性方面的新观点和建议,但是否能用这些标准取代现行方法,仍有待实践检验。

OBJECTIVE To study the suitability of pharmacokinetic method for evaluating the bioequivalence of different salbutamol metered-dose inhalers (MDIs) by comparing the result with that of the pharmacodynamic method.METHODS A two-treatment,two-period,randomized,crossover design was adopted.Single dose of 400 μg salbutamol was given to patients with mild to moderate asthma.The blood samples were collected at 0,5,10,15,20 and 30 min after administration.The plasma concentrations of salbutamol were determined by...

OBJECTIVE To study the suitability of pharmacokinetic method for evaluating the bioequivalence of different salbutamol metered-dose inhalers (MDIs) by comparing the result with that of the pharmacodynamic method.METHODS A two-treatment,two-period,randomized,crossover design was adopted.Single dose of 400 μg salbutamol was given to patients with mild to moderate asthma.The blood samples were collected at 0,5,10,15,20 and 30 min after administration.The plasma concentrations of salbutamol were determined by HPLC.Two one-sided t-tests and 90% confidence interval were used to evaluate the bioequivalence between the two products.The parameters of pulmonary function,FEV 1.0,PEF,FVC,FEF 25~75,and the safety parameter,heart rate (HR),were measured up to 6 h respectively.For all these parameters,comparisons were made by paired t-test.And those parameters with significant difference were selected for ANOVA.RESULTS The bioavailability parameters were obtained as following:c max ( 1.22±0.73) and (0.98±0.52 ) ng·mL -1,t max (0.21±0.09) and (0.26±0.08) h,AUC 0~20 min (0.25±0.10) and (0.18± 0.10) ng·h·mL -1,respectively.The relative bioavailability of the generic product was 63%.Two one-sided t-tests and 90% CI (45%~88%) demonstrated that the two salbutamol MDIs were not bioequivalent.Ventolin produced stronger bronchodilating effect than the generic product.ANOVA on the key pharmacodynamic parameters showed that the two salbutamol MDIs were not equivalent.CONCLUSIONS The bioequivalence evaluation result obtained from the pharmacokinetic method was in conformity with that from pharmacodynamic method,indicating that pharmacokinetic method was suitable for evaluating the bioequivalence of salbutamol MDIs.

目的 以药效学方法评价结果为参照 ,考察药动学方法评价沙丁胺醇气雾剂生物等效性的适用性。方法 采用随机分组、自身对照、开放试验设计 ,舒喘灵为试验制剂 ,喘乐宁为参比制剂。轻中度哮喘患者单剂量吸入沙丁胺醇 40 0 μg ,给药后0 ,5 ,10 ,15 ,2 0 ,3 0min采血 ,并在 6h内定时测定肺功能指标FEV1.0 ,PEF ,FVC和FEF2 5~ 75及不良反应指标HR。以HPLC测定血浆药物浓度 ,非房室模型计算生物利用度参数cmax,tmax,AUC0~ 2 0min和AUC0~ 30min,通过双向单侧t检验和 90 %置信区间评价生物等效性。计算FEV1.0 ,FVC ,PEF ,FEF2 5~ 75改善百分数的最大值与平均值 ,AUCΔFEV1.0 >0 ,AUCΔFEV1.0 >15% ,tΔFEV1.0 (0~ 15% ) ,tΔFEV1.0 >15% ,tmax(FEV1.0 ) ,分别进行配对t检验 ,并对有显著差异的药效学参数进行多因素方差分析。结果 两种制剂的cmax分别为 ( 1.2 2± 0 .73 )和 ( 0 .98± 0 .5 2 )ng·mL-1,tmax分...

目的 以药效学方法评价结果为参照 ,考察药动学方法评价沙丁胺醇气雾剂生物等效性的适用性。方法 采用随机分组、自身对照、开放试验设计 ,舒喘灵为试验制剂 ,喘乐宁为参比制剂。轻中度哮喘患者单剂量吸入沙丁胺醇 40 0 μg ,给药后0 ,5 ,10 ,15 ,2 0 ,3 0min采血 ,并在 6h内定时测定肺功能指标FEV1.0 ,PEF ,FVC和FEF2 5~ 75及不良反应指标HR。以HPLC测定血浆药物浓度 ,非房室模型计算生物利用度参数cmax,tmax,AUC0~ 2 0min和AUC0~ 30min,通过双向单侧t检验和 90 %置信区间评价生物等效性。计算FEV1.0 ,FVC ,PEF ,FEF2 5~ 75改善百分数的最大值与平均值 ,AUCΔFEV1.0 >0 ,AUCΔFEV1.0 >15% ,tΔFEV1.0 (0~ 15% ) ,tΔFEV1.0 >15% ,tmax(FEV1.0 ) ,分别进行配对t检验 ,并对有显著差异的药效学参数进行多因素方差分析。结果 两种制剂的cmax分别为 ( 1.2 2± 0 .73 )和 ( 0 .98± 0 .5 2 )ng·mL-1,tmax分别为 ( 0 .2 1± 0 .0 9)和 ( 0 .2 6± 0 .0 8)h。AUC0~ 2 0min分别为 ( 0 .2 5± 0 .10 )和 ( 0 .18± 0 .10 )ng·h·mL-1。舒喘灵相对于喘乐宁的生物利用度为 63 % ( 90 %CI 45 %~ 88% )。双向单侧t检验和 90 %置信区间显示两种沙丁胺醇气雾剂生物不等效。两种制剂的药效学指标AUCΔFEV1.0

Aim To develop a sensitive and specific LC/MS/MS method for direct determination of dextrorphan in human plasma and to study the pharmacokinetics of dextrorphan. Methods After a single oral dose of 60 mg dextromethorphan hydrobromide to 18 healthy Chinese male volunteers, the plasma concentration of dextrorphan, an active metabolite of dextromethorphan, was determined. Dextrorphan and internal standard chlorpheniramine were extracted from plasma using liquid liquid extraction, then separated on a Zorbax Extend...

Aim To develop a sensitive and specific LC/MS/MS method for direct determination of dextrorphan in human plasma and to study the pharmacokinetics of dextrorphan. Methods After a single oral dose of 60 mg dextromethorphan hydrobromide to 18 healthy Chinese male volunteers, the plasma concentration of dextrorphan, an active metabolite of dextromethorphan, was determined. Dextrorphan and internal standard chlorpheniramine were extracted from plasma using liquid liquid extraction, then separated on a Zorbax Extend C 18 column. The mobile phase consisted of methanol water formic acid (70∶30∶1), at a flow rate of 0 5 mL·min -1 . A Finnigan TSQ tandem mass spectrometer equipped with electrospray ionization source was used as detector and was operated in the positive ion mode. Selected reaction monitoring (SRM) using the precursor to product ion combinations of m/z 258 to 157 and m/z 275 to 230 was performed to quantify dextrorphan. The pharmacokinetic parameters of dextrorphan were calculated by non compartment model statistics. Results The linear calibration curves were obtained in the concentration range of 0 2-80 μg·L -1 . Each plasma sample was chromatographed within 3 0 min. The intra and inter day relative standard deviation (RSD) across three validation runs over the entire concentration range was less than 8%. Accuracy determined at three concentrations (0 5, 6 0 and 70 μg·L -1 for dextrorphan) ranged from 98 8% to 100 6%. Pharmacokinetic parameters of dextrorphan was obtained as follows: T max was (2 1±0 7) h, C max was (14±8) μg·L -1 , T 1/2 was (3 8±1 8) h, AUC 0-t was (60±37) μg·h·L -1 . Conclusion Plasma concentration of the active metablite dextrorphan was directly determined. The method is sensitive and convenient, and is proved to be suitable for clinical investigation of dextrorphan pharmacokinetics and bioequivalence evaluation of formulations containing dextromethorphan.

目的 建立直接测定人血浆中O 去甲右美沙芬的方法 ,并应用于药代动力学研究。方法  1 8名健康受试者单剂量po氢溴酸右美沙芬 6 0mg后 ,血浆样品经液 液萃取 ,通过液相色谱 质谱 质谱联用法测定其活性代谢物O 去甲右美沙芬的浓度 ,用非室模型计算药代动力学参数。结果 O 去甲右美沙芬测定的线性范围为 0 2~ 80μg·L- 1 ;其主要药代动力学参数Tmax 为 (2 1± 0 7)h ,Cmax为 (1 4± 8) μg·L- 1 ,T1 2 为 (3 8± 1 8)h ,用梯形法计算 ,AUC0 -t为 (6 0± 37) μg·h·L- 1 。结论 该法灵敏度高 ,操作简便 ,可直接测定活性代谢物 ,适用于右美沙芬的临床药代动力学研究及制剂的生物等效性评价

 
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