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  • 匿名
关注:1 2013-05-23 12:21

求翻译:由于是复方制剂,临床试验可能有2种情况。一种是等效(BE,约26例)(复方药代试验及检测的难度较大,有可能无法做出好的结果,那就需要进行临床验证试验)。另一种临床验证试验,须做100对(临床试验情况大致同国内注册H3.1,实际要做240例)。是什么意思?

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由于是复方制剂,临床试验可能有2种情况。一种是等效(BE,约26例)(复方药代试验及检测的难度较大,有可能无法做出好的结果,那就需要进行临床验证试验)。另一种临床验证试验,须做100对(临床试验情况大致同国内注册H3.1,实际要做240例)。
问题补充:

  • 匿名
2013-05-23 12:21:38
As the compound, clinical trials, there may be two kinds of situations. One is the equivalent (BE, about 26 cases) (compound pharmacokinetic testing and detection more difficult, there may not be able to make a good result, it requires clinical validation trials). Another clinical validation trials
  • 匿名
2013-05-23 12:23:18
正在翻译,请等待...
  • 匿名
2013-05-23 12:24:58
正在翻译,请等待...
  • 匿名
2013-05-23 12:26:38
Because it is the compound preparation, clinical trials may have 2 kinds. One is the equivalent (BE, about 26 cases) (compound drug testing and measuring of difficult, there may not be able to make good results, it is necessary for clinical validation trials). Another clinical trial, 100 pairs (clin
  • 匿名
2013-05-23 12:28:18
Because is compound preparation, the clinical trial may have 2 kinds of situations. One equivalent (BE, about 26) (compound medicine relatively large in difficulty tested and found to take the place of, probably unable to make the good result, then need to carry on test for the clinical verification
 
 
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