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    Development of LDP Sustained-release Tablets and Evaluation of Bioequivalence
    LDP缓释片的研制及生物等效性评价
    Relative Bioavailability and Bioequivalence Assessment of Domestic Amiloride Tablet
    国产氨氯吡咪片的相对生物利用度及其生物等效性评价
    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
    Studies on Bioequivalence of Domestic and Imported Tablets of Ibuprofen
    国产与进口布洛芬糖衣片生物等效性研究
    Objective To study the relative bioavailability and bioequivalence of compound glipizide in healthy volunteers.
    目的研究复方格列吡嗪片人体生物利用度及生物等效性。
    OBJECTIVE To study pharmacokinetics and bioequivalence of domestic and imported zolmitriptan tablets in Chinese healthy volunteers.
    目的在中国健康成年男性志愿者中比较研究国产和进口佐米曲坦片剂的药动学参数,评估两者的生物等效性。
    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)。
    OBJECTIVE To evaluate the bioequivalence of domestic tropisetron preparations and imported tablets.
    目的评价国产盐酸托烷司琼片、胶囊与进口参比制剂是否生物等效。
    Objective:To establish a liquid chromatography-mass spectrometry(LC-MS) method for determining the concentration of amlodipine besylate in human plasma and to evaluate the bioequivalence of 2 kinds of amlodipine besylate tablets.
    目的:建立LC-MS法测定人体血浆中苯磺酸氨氯地平的药物浓度,并进行两种制剂的生物等效性评价。
    the pharmacokinetic parameters and relative bioavailability were calculated and the bioequivalence of the 2 preparations were evaluated. Results: The pharmacokinetic parameters for experimental and the reference preparations were: C_max(6.21±1.88) vs(6.03±1.08) ng/ml; AUC_0-120(250.68±52.61) vs(246.14±52.11) ng h/ml;
    结果:苯磺酸氨氯地平供试制剂和参比制剂主要药代动力学参数如下:Cmax分别为(6.21±1.88)(、6.03±1.08)ng/ml,AUC0-120分别为(250.68±52.61)、(246.14±52.11)ng.
    Conclusion The two formulations of fleroxacin were bioequivalence.
    结论氟罗沙星的受试制剂和参比制剂在健康人体有生物等效性。
    The pharmacokinetic parameters were calculated and the bioavai-lability and bioequivalence of two formulations were evaluated by DAS program.
    用DAS药代动力学程序计算相对生物利用度并评价生物等效性。
    Objective To study the pharmacokinetics and bioequivalence of two fluconazole capsule formulations in 20 healthy volunteers who received a single oral dose of floconazle(200mg).
    目的研究氟康唑在人体中药代动力学和生物等效性。 方法20名健康志愿者随机交叉口服氟康唑两种制剂(参比制剂与受试制剂)各200mg,采用HPLC法测定血药浓度。
    The relative bioequivalence of the test preparation was(97±12)%.
    t_(1\2β)分别为(1.9±2.3)h和(1.9±1.5)h,2种制剂的主要药动学参数无显著差异(P>0.05),受试制剂的相对生物利用度为(97±12)%。
    OBJECTIVE To observe the concentration-time process of cefadroxil in 18 healthy volunteers and evaluate the bioequivalence of the three kinds of cefadroxil preparations.
    目的:研究18名健康志愿者的单剂量口服3种头孢羟氨苄制剂后的血药浓度经时过程,以及三者的生物等效性评价。
    AIM To establish a HPLC-FLU method to study the pharmacokinetics of levofloxacin in human plasma and to evaluate the bioequivalence of two domestic levofloxacin tablets.
    目的建立左氧氟沙星血药浓度的HPLC-FLU测定法,用于人体生物等效性研究。
    OBJECTIVE To evaluate the bioequivalence of enalapril maleate tablet of tested preparation and reference preparation in healthy volunteers.
    目的用HPLC-MS测定健康受试者口服马来酸依那普利制剂后的血药浓度,估算受试制剂和参比制剂的药动学参数,评价两种制剂的生物等效性和相对生物利用度。
    The concentrations of ciprofloxacin in serum samples were determined by RP-HPLC, and the bioequivalence were evaluated. RESULTS: The main pharmacokinetic parameters of the test and reference in volunteers were as follows, AUC0-t were 10.889±1.385 μ g ·h ·ml-1 and 12.406±1.384 μ g ·h ·ml-1;
    结果单剂口服给药试验制剂和参比制剂环丙沙星时间-浓度曲线下面积(AUC0-t)分别为10.889±1.385 μg ·h·ml-1和12.406±1.384 μg ·h ·ml-1;
    OBJECTS: To study the pharmacokinetics of gatifloxacin test and reference in a two-way crossover design experiments and to evaluate their bioequivalence.
    目的:进行加替沙星试验制剂与参比制剂的单剂两周期交叉试验,评价加替沙星的药代动力学特征,以及两制剂的生物等效性。
    Noncompartmental analysis was adopted to calculate the pharmacokinetic parameters including AUC0-last, Cmax, tmax, t1/2 and CL/F. Analysis of variance and two one-sided t-tests were used to evaluate the bioequivalence of the two formulations.
    以非房室模型计算药物动力学参数AUC0-last、Cmax、tmax、t1/2和CL/F,通过多因素方差分析、双单侧t检验判断两种制剂的生物等效性。
 

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