新药生殖毒性试验规范性操作介绍

生殖毒性试验是毒理学试验中较为复杂和繁琐、技术要求较高的试验。现从实验技术人员资质要求、试验前准备、试验期观察、试验记录、供试品、对照品的配制和给予、亲本动物的剖杀和检查、与专题负责人沟通确认等方面介绍作为技术人员如何做好安全性评价中的生殖毒性试验工作。

Introduction to some good practices in reproductive toxicity tests of new drugs

The importance and characteristics for the toxicity evaluation to reproduction and the developing fetus during the development of new medicines require a battery of the more complicated, elaborate and the higher technical tests than other toxicological studies. This article reviewed that step by step, attentions could be paid that concerns with the reproductive toxicity test in respects of the requirements of the technican＇s genius, the preparations for the test, the observation of experimental stage, the records of the experiment, the dispensing and administer, the dissection and checking of the parent animals, and the communication with SD, many of which can play a vital role for the success of the reproductive and developmental study.