| 龚青,仲宣惟,田洁,孙桂霞.探讨化学合成原料药中起始原料的相关要求[J].中国药事,2019,33(8):864-870 |
| 探讨化学合成原料药中起始原料的相关要求 |
| Discussion on Requirements of Starting Materials in Chemically Synthesized Drug Substances |
| 投稿时间：2019-02-26 |
| DOI：10.16153/j.1002-7777.2019.08.004 |
| 中文关键词: 化学合成原料药 起始原料 ICH Q11 案例分析 |
| 英文关键词: chemical synthesized drug substance starting materials ICH Q11 case analysis |
| 基金项目: |
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| 摘要点击次数: 1602 |
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| 中文摘要: |
| 本文在梳理国际人用药品注册技术协调会（ICH）发布的《化学药品的研发与生产》（Q11）及其问答文件（阶段4）相关要求的基础上，结合日常药学审评工作以及具体案例分析，就化学合成原料药中起始原料的选择问题及质控要求展开初步探讨。 |
| 英文摘要: |
| On the basis of the Requirements of Development and Manufacture of Drug Substances (Q11) and Questions and Answers (step 4) released by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), combined with routine evaluation work and specific case analysis, the selection of starting materials and quality control requirements for chemical synthesized drug substances were preliminarily discussed. |
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