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狗在药物化合物毒性测试中的应用。

The use of the dog in toxicity tests on pharmaceutical compounds.

作者信息

Parkinson C, Grasso P

机构信息

Centre for Medicines Research, Carshalton, Surrey, UK.

出版信息

Hum Exp Toxicol. 1993 Mar;12(2):99-109. doi: 10.1177/096032719301200202.

Abstract
  1. The preclinical animal safety testing strategy used in pharmaceutical development is generally successful, with the large majority of new medicines not causing serious toxicity in man. The use of the dog has significantly contributed to this achievement by aiding the selection of safe compounds for human trials. 2. The dog should be selected as the non-rodent species for pharmacodynamic, pharmacokinetic, metabolic and other scientific reasons, not solely for practical considerations. 3. The dog is an extremely useful laboratory animal, particularly for procedures requiring extensive handling, detailed observation or biological sampling. 4. Refinements in the use of the dog have been achieved, but further progress is desirable. Retrospective analysis of pharmaceutical toxicity data could encourage the regulatory flexibility necessary for further progress.
摘要
  1. 药物研发中使用的临床前动物安全性测试策略总体上是成功的,绝大多数新药在人体中不会引起严重毒性。狗的使用通过帮助筛选用于人体试验的安全化合物,对这一成果做出了重大贡献。2. 出于药效学、药代动力学、代谢及其他科学原因,而非仅仅出于实际考虑,应选择狗作为非啮齿类动物。3. 狗是一种极其有用的实验动物,尤其适用于需要大量操作、详细观察或生物采样的程序。4. 在狗的使用方面已取得改进,但仍需进一步进展。对药物毒性数据的回顾性分析可能会促进取得进一步进展所需的监管灵活性。

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