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  • 匿名
关注:1 2013-05-23 12:21

求翻译:The assessment of the pharmacokinetic, toxicokinetic, and metabolism data should address the relevance of the analytical methods used, the pharmacokinetic models, and the derived parameters. It might be appropriate to cross-refer to more detailed consideration of certain issues within the pharmacology or toxicology studies (e.g. impact of the disease states, changes in physiology, anti-product antibodies, cross-species consideration of toxicokinetic data). Inconsistencies in the data should be discussed. Inter-species comparisons of metabolism and systemic exposure comparisons in animals and humans (AUC, Cmax, and other appropriate parameters) should be discussed and the limitations and utility of the nonclinical studies for prediction of potential adverse effects in humans highlighted.是什么意思?

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The assessment of the pharmacokinetic, toxicokinetic, and metabolism data should address the relevance of the analytical methods used, the pharmacokinetic models, and the derived parameters. It might be appropriate to cross-refer to more detailed consideration of certain issues within the pharmacology or toxicology studies (e.g. impact of the disease states, changes in physiology, anti-product antibodies, cross-species consideration of toxicokinetic data). Inconsistencies in the data should be discussed. Inter-species comparisons of metabolism and systemic exposure comparisons in animals and humans (AUC, Cmax, and other appropriate parameters) should be discussed and the limitations and utility of the nonclinical studies for prediction of potential adverse effects in humans highlighted.
问题补充:

  • 匿名
2013-05-23 12:26:38
药代动力学评价棉铃虫和代谢数据应解决使用的分析方法的关联性、 药代动力学模型和派生的参数。它可能是适当巨量 (例如影响疾病状态,变化生理、 anti-product 抗体、 跨物种审议的棉铃虫数据) 的药理学或毒理学研究中的某些问题的更多详细审议。应该讨论中的数据不一致的地方。异种比较的代谢和动物和人类 (自卫军 Cmax 和其他适当的参数) 的全身暴露比较应讨论,并强调限制和预测潜在的不利影响,在人类中的非临床研究的实用程序。
 
 
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