| 药品杂质控制与评价研究进展 |
| |
| 作者姓名： | 王维剑 刘斐 牛冲 谢纪珍 祝清芬 胡德福 |
| |
| 作者单位： | 1. 山东省食品药品检验研究院,山东 济南,250101;2. 山东省食品药品监督管理局审评认证中心,山东 济南,250014 |
| |
| 基金项目： | 国家科技重大专项课题-重大新药创制(2009ZX09313-023) |
| |
| 摘 要： | 杂质作为影响药品安全有效性的关键因素，一直是药品质量研究、安全性评价的重点。本文围绕药品杂质控制与杂质的安全性评价2个方面，对杂质谱研究、杂质毒理学评价、杂质对照品制备等热点领域的研究现状进行了综述。
|
| 关 键 词： | 杂质谱 基因毒性 对照品 |
Research advances on drug impurity control and safety evaluation |
| |
| Authors: | WANG Weijian LIU Fei NIU Chong XIE Jizhen ZHU Qingfen and HU Defu |
| |
| Affiliation: | 1.Shandong Institute for Food and Drug Control,Jinan 250101,China; 2.Shandong Center for Drug Evaluation and Certification,Jinan 250014,China,1.Shandong Institute for Food and Drug Control,Jinan 250101,China; 2.Shandong Center for Drug Evaluation and Certification,Jinan 250014,China,1.Shandong Institute for Food and Drug Control,Jinan 250101,China; 2.Shandong Center for Drug Evaluation and Certification,Jinan 250014,China,1.Shandong Institute for Food and Drug Control,Jinan 250101,China; 2.Shandong Center for Drug Evaluation and Certification,Jinan 250014,China,1.Shandong Institute for Food and Drug Control,Jinan 250101,China; 2.Shandong Center for Drug Evaluation and Certification,Jinan 250014,China and 1.Shandong Institute for Food and Drug Control,Jinan 250101,China; 2.Shandong Center for Drug Evaluation and Certification,Jinan 250014,China |
| |
| Abstract: | As a key factor affecting the safety and effectiveness of drugs,impurity has always been the focus of drug quality research and safety evaluation.This paper focused on the two aspects of drug impurity control and safety evaluation, and summarized the research status of impurity profile,impurity toxicology evaluation,impurity reference substance prepara-tion and so on. |
| |
| Keywords: | Impurity profile Toxicology evaluation Reference substance |
| 本文献已被 万方数据 等数据库收录！ |
| 点击此处可从《》浏览原始摘要信息 |
|
点击此处可从《》下载全文 |
|
