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  • 匿名
关注:1 2013-05-23 12:21

求翻译:The Integrated Overview and Conclusions should clearly define the characteristics of the human pharmaceutical as demonstrated by the nonclinical studies and arrive at logical, well-argued conclusions supporting the safety of the product for the intended clinical use. Taking the pharmacology, pharmacokinetics, and toxicology results into account, the implications of the nonclinical findings for the safe human use of the pharmaceutical should be discussed (i.e., as applicable to labeling).是什么意思?

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The Integrated Overview and Conclusions should clearly define the characteristics of the human pharmaceutical as demonstrated by the nonclinical studies and arrive at logical, well-argued conclusions supporting the safety of the product for the intended clinical use. Taking the pharmacology, pharmacokinetics, and toxicology results into account, the implications of the nonclinical findings for the safe human use of the pharmaceutical should be discussed (i.e., as applicable to labeling).
问题补充:

  • 匿名
2013-05-23 12:26:38
集成概述和结论应明确定义的人类医药特征,如非临床研究和逻辑、 有力的结论临床使用目的支持产品的安全性。考虑到的药理作用、 药代动力学和毒理学结果,安全的人用药品的非临床结果的影响应讨论 (即,作为适用于标记)。
 
 
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