| 生殖毒性试验的质量保证 |
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| 引用本文： | 韩铁,吴纯启,廖明阳. 生殖毒性试验的质量保证[J]. 中国新药杂志, 2006, 15(12): 941-945 |
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| 作者姓名： | 韩铁 吴纯启 廖明阳 |
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| 作者单位： | 军事医学科学院毒物药物研究所,北京,100850 |
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| 摘 要： | 生殖毒性试验是毒理学试验中最为复杂、繁琐,技术要求最高的试验,在药品非临床研究质量管理规范（GLP）和质量保证（QA）检查方面有其特殊性.现从实验室资质的确认、试验关键阶段的检查、研究资料和报告的审查、特殊评价项目的质量保证和现场检查等5个方面介绍生殖毒性试验质量保证的程序、要求和注意事项.
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| 关 键 词： | 生殖毒性 质量保证 药品非临床研究质量管理规范 |
| 文章编号： | 1003-3734（2006）12-0941-05 |
| 收稿时间： | 2005-12-30 |
| 修稿时间： | 2005-12-30 |
Quality assurance of reproductive toxicity tests |
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| HAN Tie,WU Chun-qi,LIAO Ming-yang. Quality assurance of reproductive toxicity tests[J]. Chinese Journal of New Drugs, 2006, 15(12): 941-945 |
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| Authors: | HAN Tie WU Chun-qi LIAO Ming-yang |
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| Affiliation: | Institute of Toxicology and Pharmacology, Academy of Military Medical Sciences, Beijing 100850, China |
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| Abstract: | The potential for toxicity to reproduction and the developing fetus during the develop- ment of new medicines results in a battery of the most complicated,elaborate and the highest technical tests that can cover certain aspects of toxicological tests.These tests are conducted in full compliance with the GLP and quality assurance(QA)of non-clinical researches of medicines.This article comprehensive- ly reviews the program,requirements and alerts of the quality assurance for the reproductive toxicity tests in respect of the testing facility qualification,the critical phase validation,the audit of the protocols and study reports,the quality assurance for special evaluation items,and the on-site inspections. |
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| Keywords: | reproductive toxicity quality assurance good laboratory practice(GLP) |
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