Scales M D
Glaxo Group Research Limited, Ware, Herts, UK.
Adverse Drug React Toxicol Rev. 1992 Spring;11(1):5-12.
Based upon the recommendations given by the ICH outlined in this document, it is proposed that: 1. In rodents, single dose toxicity studies should be conducted using as few animals as possible. 2. Single dose toxicity studies in non-rodents will not be performed except possibly as a component of dose escalation studies. 3. Recovery animals on repeat dose studies will not be monitored for delayed toxicity. 4. Twelve month rodent studies will not be performed. 5. Twelve month non-rodent studies will be performed for chronic therapies except in the few circumstances when the ICH exclusion criteria can be met. 6. EEC protocols for reproductive toxicology studies will be followed until a new guideline is issued. 7. Consultation with regulatory authorities, especially the FDA, may be required to set the doses to be used in carcinogenicity studies.
根据本文件中概述的国际协调会议（ICH）给出的建议，提议如下：1. 在啮齿动物中，单剂量毒性研究应使用尽可能少的动物进行。2. 非啮齿动物的单剂量毒性研究除非可能作为剂量递增研究的一部分，否则将不进行。3. 重复剂量研究中的恢复动物将不监测延迟毒性。4. 不进行为期十二个月的啮齿动物研究。5. 除了少数能够符合ICH排除标准的情况外，慢性疗法将进行为期十二个月的非啮齿动物研究。6. 在新指南发布之前，将遵循欧洲经济共同体（EEC）生殖毒理学研究方案。7. 可能需要与监管当局，特别是美国食品药品监督管理局（FDA）进行磋商，以确定致癌性研究中使用的剂量。
