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study bioequivalence
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  生物等效性研究
     CONCLUSION The method is simple,rapid,accurate and can be used to study bioequivalence of lorazepam.
     结论本法专属、灵敏、快速,适用于劳拉西泮的生物等效性研究
短句来源
     Objective To establish a simple HPLC method to determine the Gliclazide hydrochloride in human plasma and to study bioequivalence,and to optimize this methods.
     目的建立一种简便的格列齐特血药浓度HPLC测定和生物等效性研究测定方法,并使此方法达最佳优化状态。
短句来源
     AIM To study bioequivalence of bambuteral and its metablites terbutaline in 20 healthy male volunteers.
     目的 研究国产班布特罗片剂和进口片剂进行人体生物等效性研究
短句来源
  “study bioequivalence”译为未确定词的双语例句
     OBJECTIVE: To study bioequivalence of cefuroxime axetil tablets.
     目的:评价国产头孢呋辛酯片的生物等效性。
短句来源
     AIM: To study bioequivalence of paracetamol/caffeine granules and tablets.
     目的 :研究酚咖颗粒剂和片剂的人体生物等效性。
短句来源
  相似匹配句对
     Study on Bioequivalence of Polyferose Capsules
     多糖铁胶囊的人体生物等效性研究
短句来源
     The study of C.
     目前各国学者不但研究了各海区C.
短句来源
     Study on Bioequivalence of Famciclovir Tablets
     伐昔洛韦片的人体生物等效性研究
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     Of Study
     论读书
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OBJECTIVE: To study bioequivalence of cefuroxime axetil tablets. METHODS: The bioequivalence and relative bioavailability of a test domestic formulation of cefuroxime axetil in comparison with a reference imported formulation was investigated in a randomized 2-way cross-over study in 24 healthy volunteers following a single oral dose of 500 mg. The washout period is one week. A microbiological assay was used to determine the plasma levels of cefuroxime. RESULTS: The following pharmacokinetic...

OBJECTIVE: To study bioequivalence of cefuroxime axetil tablets. METHODS: The bioequivalence and relative bioavailability of a test domestic formulation of cefuroxime axetil in comparison with a reference imported formulation was investigated in a randomized 2-way cross-over study in 24 healthy volunteers following a single oral dose of 500 mg. The washout period is one week. A microbiological assay was used to determine the plasma levels of cefuroxime. RESULTS: The following pharmacokinetic parameters were derived from the individual plasma concentration time courses and the main parameters for test and reference formulations, Tmax were 2.23±0.33 h and 2.13±0.54 h, Cmax were 3.97±0.55 and 4.16±0.67 mg·L-1, T1/2ke were 1.14±0.13 and 1.15±0.15 h, AUC0-t were 10.57±1.91 and 10.60±1.97 mg·h·L-1, respectively. Compared with reference formulation, the relative bioavailability (F) of test formulation was 100.6±13.1%. The above parameters obtained from two formulations were compared by analysis of variance (ANOVA) and no significant difference was found. The bioequivalence of two formulations was found assessed by a two one-sided test(P<0.05). CONCLUSION: Therefore, from the results of this study it can be concluded that the test formulation is bioequivalent with the reference formulation.

目的:评价国产头孢呋辛酯片的生物等效性。方法:24名健康志愿者随机交叉,自身对照口服单剂量国产头孢呋辛酯片及进口头孢呋辛酯片各500 mg后,进行人体相对生物利用度以及生物等效性研究。服药间隔为1周。血药浓度测定采用微生物法。结果:受试头孢呋辛酯片及参比头孢呋辛酯片的实测平均达峰时间Tmax分别为2.23±0.33 h和2.13±0.54 h;平均峰浓度Cmax分别为3.97±0.55和4.16±0.67 mg·L-1;消除半衰期T1/2ke分别为1.14±0.13及1.15±0.15 h。血药浓度-时间曲线下面积AUC0-t分别为10.57±1.91及10.60±1.97 mg·h·L-1;受试药与参比药比较,相对生物利用度F为100.6±13.1%。Tmax 、Cmax 与AUC0-t经生物等效性检验(双向单侧t检验)P<0.05。结论:国产头孢呋辛酯片与进口参比头孢呋辛酯片相比,其人体相对生物利用度为100.6±13.1%,且两制剂具生物等效性。

AIM To study bioequivalence of bambuteral and its metablites terbutaline in 20 healthy male volunteers. METHODS A single oral dose of domestic or imported bambuteral tablet was given according to a randomized 2 way cross over design. The plasma bambuteral and terbutaline concentrations were determined by HPLC/MS. RESULTS The pharmacokinetic parametrs of domestic and imported bambuteral: AUC 0-t were (52±21) μg·h·L -1 and (51±20) μg·h·L -1 , T max were (2 9±0 9) h and (2 6±0...

AIM To study bioequivalence of bambuteral and its metablites terbutaline in 20 healthy male volunteers. METHODS A single oral dose of domestic or imported bambuteral tablet was given according to a randomized 2 way cross over design. The plasma bambuteral and terbutaline concentrations were determined by HPLC/MS. RESULTS The pharmacokinetic parametrs of domestic and imported bambuteral: AUC 0-t were (52±21) μg·h·L -1 and (51±20) μg·h·L -1 , T max were (2 9±0 9) h and (2 6±0 7) h, C max were (6 0±2 6) μg·L -1 and (6 2±2 9) μg·L -1 , T 1/2 K e were (11 2±2 3) h and (11 2±1 9) h, respectively; terbutaline: AUC 0-t were (191±30) μg·h·L -1 and (197±37) μg·h·L -1 ; T max were (4 2±1 0) h and (4 2±1 0) h; C max were (10±5) μg·L -1 and (10±4) μg·L -1 ; T 1/2 K e were (20±3) h and (21±4) h, respectively. The bioavaiability of the domestics was 102%±8% (bambuteral) and 100%±12% (terbutaline). CONCLUSION The results demonstrate that the two forms of bambuteral and terbutaline were bioequivalent by analysis of variance, two one sided test and 90% confidential limit.

目的 研究国产班布特罗片剂和进口片剂进行人体生物等效性研究。方法  2 0名健康受试者随机交叉给药 ,用液相色谱 /质谱联用测定血浆中班布特罗其代谢物特布他林的浓度。结果 经数据处理 ,单次口服国产和进口班布特罗片剂后班布特罗的药代动力学参数 :AUC0 -t分别为 (5 2± 2 1) μg·h·L-1和 (5 1± 2 0 ) μg·h·L-1,Tmax分别为 (2 9± 0 9)h和 (2 6± 0 7)h ,Cmax分别为 (6 0± 2 6 ) μg·L-1和 (6 2± 2 9) μg·L-1。特布他林 :AUC0 -t分别为 (191± 30 ) μg·h·L-1和 (197± 37) μg·h·L-1,Tmax分别为 (4 2± 1 0 )h和 (4 2± 1 0 )h ,Cmax分别为 (10± 5 )μg·L-1和 (10± 4) μg·L-1。国产班布特罗片剂单次给药后的相对生物利用度为 10 2 %± 8% (班布特罗 ) ,10 0 %±12 % (特布他林 )。结论 经统计学证明两制剂有生物等效性

AIM: To study bioequivalence of paracetamol/caffeine granules and tablets. METHODS: The plasma concentrations of paracetamol and caffeine were determined by high performance liquid chromatography (HPLC) method after granules and tablets were given to 18 healthy volunteers in an open randomized crossover trials. RESULTS: The concentration time curves of paracetamol/caffeine were conformed to an one compartment open model with first order absorption. The main pharmacokinetic parameters of paracetamol/caffeine...

AIM: To study bioequivalence of paracetamol/caffeine granules and tablets. METHODS: The plasma concentrations of paracetamol and caffeine were determined by high performance liquid chromatography (HPLC) method after granules and tablets were given to 18 healthy volunteers in an open randomized crossover trials. RESULTS: The concentration time curves of paracetamol/caffeine were conformed to an one compartment open model with first order absorption. The main pharmacokinetic parameters of paracetamol/caffeine granules and tablets were as follows. Paracetamol: AUC 0 12 h (54 79±12 25) and (54 82±12 79) μg/ml·h, c max (15 35±2 69) and (14 99±2 79) μg/ml, t max (0 74±0 14) and (0 82±0 33) h, T 1/2ke (2 45±0 40) and (2 34±0 42) h; Caffeine: AUC 0 24 h (28 59±6 57) and (27 06±5 04) μg/ml·h, c max (3 06±0 52) and (2 88±0 43) μg/ml, t max (0 95±0 42) and (1 00±0 50) h, T 1/2ke (6 30±0 83) and (6 44±0 74) h, respectively. There were no significant differences between 2 formulations ( P >0 05). The relative bioavailability of paracetamol granules was (101 28±14 18)%, the relative bioavailability of caffeine granules was (105 72±14 04)%. CONCLUSION: The result of the statistical analysis shows that the 2 formulations are bioequivalent.

目的 :研究酚咖颗粒剂和片剂的人体生物等效性。方法 :18名健康男性志愿者随机交叉口服酚咖颗粒剂和片剂 ,取不同时间点的静脉血 ,用高效液相色谱法测定血浆药物浓度。结果 :试验数据经 3P97软件运算的血药浓度 -时间曲线拟合表明 ,该药物符合体内一房室模型。颗粒剂与片剂中对乙酰氨基酚 AUC0 - 1 2 h分别为 (5 4.79± 12 .2 5 )与 (5 4.82± 12 .79)︼g/ml· h,cmax分别为 (15 .35± 2 .6 9)与 (14.99± 2 .79)︼g/m l,tmax分别为 (0 .74± 0 .14)与 (0 .82± 0 .33) h,T1 / 2 ke分别为 (2 .45± 0 .40 )与(2 .34± 0 .42 ) h;咖啡因 AUC0 - 2 4h分别为 (2 8.5 9± 6 .5 7)与 (2 7.0 6± 5 .0 4) ︼g/m l· h,cmax分别为 (3.0 6± 0 .5 2 )与 (2 .88± 0 .43)︼g/m l,tmax分别为 (0 .95± 0 .42 )与 (1.0 0± 0 .5 0 ) h,T1 / 2 ke分别为 (6...

目的 :研究酚咖颗粒剂和片剂的人体生物等效性。方法 :18名健康男性志愿者随机交叉口服酚咖颗粒剂和片剂 ,取不同时间点的静脉血 ,用高效液相色谱法测定血浆药物浓度。结果 :试验数据经 3P97软件运算的血药浓度 -时间曲线拟合表明 ,该药物符合体内一房室模型。颗粒剂与片剂中对乙酰氨基酚 AUC0 - 1 2 h分别为 (5 4.79± 12 .2 5 )与 (5 4.82± 12 .79)︼g/ml· h,cmax分别为 (15 .35± 2 .6 9)与 (14.99± 2 .79)︼g/m l,tmax分别为 (0 .74± 0 .14)与 (0 .82± 0 .33) h,T1 / 2 ke分别为 (2 .45± 0 .40 )与(2 .34± 0 .42 ) h;咖啡因 AUC0 - 2 4h分别为 (2 8.5 9± 6 .5 7)与 (2 7.0 6± 5 .0 4) ︼g/m l· h,cmax分别为 (3.0 6± 0 .5 2 )与 (2 .88± 0 .43)︼g/m l,tmax分别为 (0 .95± 0 .42 )与 (1.0 0± 0 .5 0 ) h,T1 / 2 ke分别为 (6 .30± 0 .83)与 (6 .44± 0 .74) h。酚咖颗粒剂与片剂的主要药物动力学参数比较 ,经方差分析和双向单侧 t检验 ,差异无统计学意义 (P>0 .0 5 )。对乙酰氨基酚颗粒剂相对于片剂的生物利用度为 (10 1.2 8± 14.18) % ,咖啡因颗粒剂相对于片剂的生物利用度为 (10 5 .72± 14.0 4) %。结论 :两制剂体内过程相仿 ,具有生物等效性

 
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