| 我国实施ICH S系列技术指导原则的策略研究 |
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| 引用本文： | 杨建红,韩鹏,张彦彦,马玉琴,陈宁,陈震.我国实施ICH S系列技术指导原则的策略研究[J].现代药物与临床,2018,33(7):1843-1847. |
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| 作者姓名： | 杨建红 韩鹏 张彦彦 马玉琴 陈宁 陈震 |
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| 作者单位： | 沈阳药科大学亦弘商学院;郑州大学药物研究院 |
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| 基金项目： | 国家食品药品监督管理总局药化注册司资助项目 |
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| 摘 要： | 通过对ICH S系列指导原则与我国相应技术指导原则的对比研究,分析我国与ICH在药品注册非临床技术要求方面的主要差异。通过对公众、专家、企业进行问卷调查,摸清ICH S系列指导原则在我国的认知和实施基础。在对比研究和问卷调查的基础上,结合ICH的要求,提出了ICH S系列指导原则在我国实施的建议。
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| 关 键 词： | ICH S系列 技术指导原则 对比研究 问卷调查 |
| 收稿时间： | 2018/4/26 0:00:00 |
Strategic research on implementation of ICH Safety Guidelines in China |
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| YANG Jian-hong,HAN Peng,ZHANG Yan-yan,MA Yu-qin,CHEN Ning and CHEN Zhen.Strategic research on implementation of ICH Safety Guidelines in China[J].Drugs & Clinic,2018,33(7):1843-1847. |
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| Authors: | YANG Jian-hong HAN Peng ZHANG Yan-yan MA Yu-qin CHEN Ning and CHEN Zhen |
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| Institution: | School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China,Institute of Drug Discovery & Development, Zhengzhou University, Zhengzhou 450001, China and School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China;Institute of Drug Discovery & Development, Zhengzhou University, Zhengzhou 450001, China |
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| Abstract: | Through the comparative study of ICH Safety Guidelines and corresponding Chinese technical guidelines, the main differences in non-clinical technical requirements for drug registration between China and ICH are analyzed. Through questionnaire survey to the public, experts and enterprises, the cognition and implementation basis of ICH Safety Guidelines in China are found out. On the basis of comparative study and questionnaire survey, combined with the requirements of ICH, the implementation proposals of ICH Safety Guidelines in China are put forward in this paper. |
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| Keywords: | ICH Safety Guidelines technical guidelines comparative study questionnaire survey |
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