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实验研究的结果在预测药物对人体的不良副作用方面能在多大程度上进行外推?

To what extent can results of experimental studies be extrapolated in predicting adverse side effects of drugs in man?

作者信息

Grimová J, Roubal Z, Dlabac A

出版信息

Arch Toxicol Suppl. 1986;9:240-3. doi: 10.1007/978-3-642-71248-7_34.

Abstract

A new potential antiinflammatory substance serves as an example that substantiates the necessity of carrying out concurrent comparative pharmacokinetic and biotransformation studies of new drugs in experimental animals and man during the preclinical research stage, with adherence to all safety precautions. Such a procedure will facilitate the choice of an animal model that approaches human metabolism and pharmacokinetics as closely as possible. This serves in the further development of the test drug, and thus enhances the validity of the transfer of experimental data to man, especially from the toxicological aspect.

摘要

一种新的潜在抗炎物质可作为一个实例,它证实了在临床前研究阶段,在实验动物和人体中对新药进行同步比较药代动力学和生物转化研究并严格遵守所有安全预防措施的必要性。这样的程序将有助于选择尽可能接近人类代谢和药代动力学的动物模型。这有助于受试药物的进一步开发,从而提高将实验数据外推至人体的有效性,尤其是从毒理学角度来看。

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