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生殖发育毒性研究是药物安全性评价的重要组成部分,形态学观察是生殖发育毒性研究中关键环节,在形态学检查中往往缺少标准化的程序,导致检查结果一致性差,对最终评价结果产生影响。因此形态学观察的标准化是发展和完善生殖发育毒性评价的最佳途径,本文通过综述生殖发育毒性诊断标准、术语、结果和讨论方面存在的问题及标准化的途径,深入探讨如何在生殖发育毒性安全性评价中形成统一的、完全接受和认可的标准化检查和评价程序。
Reproductive and developmental toxicity study is an important part of drug safety evaluation. Morphological observation is the key link in the study of reproductive and developmental toxicity. In morphological examination, there is a lack of standardized procedures, leading to poor consistency of test results and impact on the final evaluation results. Therefore, the standardization of morphological observation is the best way to develop and perfect the assessment of reproductive and developmental toxicity. This paper explores how to evaluate the safety of reproductive and developmental toxicity by reviewing the diagnostic criteria, terms, results and discussion of reproductive and developmental problems and standardization approaches Sex assessment in the formation of a unified, fully accepted and recognized standardization inspection and evaluation procedures.