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   bioequivalence 在 临床医学 分类中 的翻译结果: 查询用时:0.131秒
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bioequivalence
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  生物等效性
    Objective To evaluate the performance of ACL 300 for measuring low molecular weight heparin(LMWH) and observe the bioequivalence of domestic and imported LMWH.
    目的对ACL300全自动血凝仪测定低分子肝素(LMWH)进行评价,并对国产低分子肝素钙与进口参比制剂速避凝进行人体生物等效性对比。
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    Objective To evaluate the performance of ACL 300 for measuring low molecular weight heparin(LMWH) and observe the bioequivalence of domestic and imported LMWH.
    目的对ACL300全自动血凝仪测定低分子肝素(LMWH)进行评价,并对国产低分子肝素钙与进口参比制剂速避凝进行人体生物等效性对比。
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  bioequivalence
The method was successfully applied to investigate the bioequivalence between two kinds of tablets (test versus reference products) in 18 healthy male Chinese volunteers.
      
Bioanalytical laboratories support a range of regulatory studies ranging from early toxicology studies through Phase 1,2 and 3 clinical studies to definitive bioequivalence and bioavailabity studies in support of the marketed product.
      
With a total run-time of 6 minutes, the method was suitable for supporting clinical studies and applied to the analysis of samples from a bioequivalence study.
      
A new sensitive HPLC-FLD method has been developed and validated for the determination of cisapride in human plasma for a bioequivalence study.
      
This method has been successfully used to support a bioequivalence clinical study.
      
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Objective To evaluate the performance of ACL 300 for measuring low molecular weight heparin(LMWH) and observe the bioequivalence of domestic and imported LMWH. Methods Anti-X activity of LMWH in the plasma was measured by ACL 300. Results Within-day and between-day coefficients of variation(CV) were lower than 10%,except for low ranges CV between-day,carryover was lower than 0.4%.There was a good linearity of LMWH from 0.0 IUAXa/ml to 1.0 IUAXa/ml.The main pharmacokinetics of the two products were as follow:peak...

Objective To evaluate the performance of ACL 300 for measuring low molecular weight heparin(LMWH) and observe the bioequivalence of domestic and imported LMWH. Methods Anti-X activity of LMWH in the plasma was measured by ACL 300. Results Within-day and between-day coefficients of variation(CV) were lower than 10%,except for low ranges CV between-day,carryover was lower than 0.4%.There was a good linearity of LMWH from 0.0 IUAXa/ml to 1.0 IUAXa/ml.The main pharmacokinetics of the two products were as follow:peak time(T_(max)) were(2.97±0.53) h and(3.31±0.69) h,peak concentration(C_(max)) were(0.68±0.08) IUAXa/ml and(0.64±0.09) IUAXa/ml,area under the curve(AUC_(0-t)) were(5.38±(0.79)(IUAXa/ml)·h) and((5.03±0.73)(IUAXa/ml)·h.) Conclusions Precision,carryover and linearity studies of measuring LMWH by ACL300 were good.Domestic reagent and imported reagent shows bioequivalence.

目的对ACL300全自动血凝仪测定低分子肝素(LMWH)进行评价,并对国产低分子肝素钙与进口参比制剂速避凝进行人体生物等效性对比。方法采用Heparin试剂盒在ACL300全自动血凝仪上测定血浆中LMWH抗Xa因子活性。结果日内精密度(变异系数,CV)均<10%,日间精密度中的高值、中值CV<10%,低值>10%(21.0%),携带污染率<0.4%,LMWH浓度在0.00 IUAXa/m l和1.0 IUAXa/m l内线性良好;国产低分子肝素钙与参比制剂的血药峰值时间(Tm ax)分别为(2.97±0.53)h和(3.31±0.69)h,血药峰值浓度(Cm ax)分别为(0.68±0.08)IUAXa/m l和(0.64±0.09)IUAXa/m l,曲线下面积(AUC0-t)分别为(5.38±0.79)(IUAXa/m l).h和(5.03±0.73)(IUAXa/m l).h。结论ACL300全自动血凝仪测定LMWH时的精密度、携带污染率和线性良好,经生物等效性计算程序处理,相同剂量被试制剂与参比制剂为生物等效制剂。

 
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