| 必须重视中药新药质量标准和制剂稳定性的研究 |
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| 引用本文： | 孔英梅,唐欣时.必须重视中药新药质量标准和制剂稳定性的研究[J].中药新药与临床药理,1993(2). |
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| 作者姓名： | 孔英梅 唐欣时 |
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| 作者单位： | 卫生部药品审评办公室，卫生部药品审评办公室 北京 100050，北京 100050 |
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| 摘 要： | 从审评工作的角度,提出我国要研制出在世界上有竞争力、安全有效的中药新药,必须重视中药新药质量标准和制剂稳定性的研究。同时,应加强新药审批办法的学习,以提高中药新药的申报水平。
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| 关 键 词： | 药物评价 质量控制 药物稳定性 |
Research in Quality Standard and Stability of Chinese New Drug Must be Emphasizied |
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| Kong Yingmei Tang Xinshi.Research in Quality Standard and Stability of Chinese New Drug Must be Emphasizied[J].Traditional Chinese Drug Research & Clinical Pharmacology,1993(2). |
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| Authors: | Kong Yingmei Tang Xinshi |
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| Abstract: | From the view point of drug approval, the research in quality standard and stability of Chinese new drug must be emphasized in order to produce safe and effective new drugs which are competitive in the world. Forthermore, the regulations for new drug approval should be learned repeatedly so as to raise the level of new drug application. |
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| Keywords: | DRUG EVALUATION QUALITY CONTROL DRUG STABILITY |
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