| 新药（化学药品）申报中存在的问题与对策 |
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| 引用本文： | 程鲁榕. 新药（化学药品）申报中存在的问题与对策[J]. 中国药事, 2001, 15(3): 169-171 |
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| 作者姓名： | 程鲁榕 |
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| 作者单位： | 国家药品监督管理局药品审评中心 北京 100050 |
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| 摘 要： | 本文小结了1999年177项新药（化学药品）申报品种的专家初步技术审评意见；根据化学药品的五种类别，对申报资料中存在的问题进行了分析，提出了几点建议供新药申报者参考。
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| 关 键 词： | 化学药品 新药申报 新药审评 |
The Problem and Countermeasure on the New Drug (Chemical Drugs) Application |
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| Cheng Lurong. The Problem and Countermeasure on the New Drug (Chemical Drugs) Application[J]. Chinese Pharmaceutical Affairs, 2001, 15(3): 169-171 |
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| Authors: | Cheng Lurong |
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| Abstract: | The preliminary technical expertise of 177 new drug evaluation data sheet applied for the new drugs (chemical drugs) in 1999 was summarized in this paper. Problems existing in application dossier are analyzed, and the way to deal with the situation are offered based on 5 classes of chemical drugs. |
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| Keywords: | chemical drugs new drug application new drug evaluation problem countermeasure |
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