| 我国生物制品非临床安全性评价指导原则与ICH S6(R1)指导原则的对比研究及实施建议 |
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| 引用本文： | 吕鹏,田心,常维维,董田甜,唐晓闻,王祥建.我国生物制品非临床安全性评价指导原则与ICH S6(R1)指导原则的对比研究及实施建议[J].现代药物与临床,2018,33(10):2749-2752. |
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| 作者姓名： | 吕鹏 田心 常维维 董田甜 唐晓闻 王祥建 |
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| 作者单位： | 正大天晴药业集团股份有限公司 |
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| 摘 要： | 通过综述CDE及ICH对生物制品非临床安全性评价的指导原则的内容,比较了不同机构对生物制品非临床安全性评价要求,包括ICHS6(R1)指导原则和国内相关领域指导原则的对应关系、我国指导原则与ICHS6(R1)的差异等内容,对ICH S6(R1)在我国实施存在的技术困难和法规方面的障碍进行了讨论,并根据CDE和ICH的指导原则的差异对比情况对我国实施ICH S6(R1)给出了建议,以期为生物制品非临床安全性评价提供借鉴。
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| 关 键 词： | 生物制品 ICH S6(R1) 非临床 安全性评价 指导原则 |
| 收稿时间： | 2018/8/17 0:00:00 |
Comparison on guideline from CDE/ICH S6(R1) and suggestions for preclinical safety evaluation of biological products and feasibility of implementation in domestic |
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| L&#; Peng,TIAN Xin,CHANG Wei-wei,DONG Tian-tian,TANG Xiao-wen and WANG Xiang-jian.Comparison on guideline from CDE/ICH S6(R1) and suggestions for preclinical safety evaluation of biological products and feasibility of implementation in domestic[J].Drugs & Clinic,2018,33(10):2749-2752. |
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| Authors: | L&#; Peng TIAN Xin CHANG Wei-wei DONG Tian-tian TANG Xiao-wen and WANG Xiang-jian |
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| Institution: | Chia Tai Tian Qing Pharmaceutical Group Co., Nanjing 210023, China,Chia Tai Tian Qing Pharmaceutical Group Co., Nanjing 210023, China,Chia Tai Tian Qing Pharmaceutical Group Co., Nanjing 210023, China,Chia Tai Tian Qing Pharmaceutical Group Co., Nanjing 210023, China,Chia Tai Tian Qing Pharmaceutical Group Co., Nanjing 210023, China and Chia Tai Tian Qing Pharmaceutical Group Co., Nanjing 210023, China |
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| Abstract: | The study of guidelines for preclinical safety evaluation of biological products from CDE and ICH were reviewed in this paper. The requirements of biological products evaluation were compared between different agencies, including the relationship and differences between ICH S6(R1) guideline and the corresponding related field in domestic. Meanwhile the technical difficulties of ICH S6(R1) in the feasibility of implementation in domestic and the obstacles involved laws and regulations were discussed. Then according to the guidelines comparison between the CDE and ICH, suggestions were expected to supply reference for the local preclinical safety evaluation of biological products. |
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| Keywords: | biological products ICH S6(R1) preclinical safety evaluation guideline |
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