医药生物技术专栏 |
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关于我国药典重组DNA技术产品总论的思考 |
高凯1, 任跃明2, 王兰1, 郭中平2, 王军志1 |
1 中国食品药品检定研究院 北京 100050;
2 国家药典委员会 北京 100061 |
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Points to Consider for the General Monograph of Products Rrepared by Recombinant DNA Technology in Chinese Pharamacopeia |
GAO Kai1, REN Yue-ming2, WAN Lan1, GUO Zhong-ping2, WANG Jun-zhi1 |
1 Chinese National Institute for Food and Drug Control, Beijing 100050;
2 Chinese Pharmacopoeia Commission, Beijing 100061 |
引用本文:
高凯, 任跃明, 王兰, 郭中平, 王军志. 关于我国药典重组DNA技术产品总论的思考[J]. 中国生物工程杂志, 2014, 34(5): 107-115.
GAO Kai, REN Yue-ming, WAN Lan, GUO Zhong-ping, WANG Jun-zhi. Points to Consider for the General Monograph of Products Rrepared by Recombinant DNA Technology in Chinese Pharamacopeia. China Biotechnology, 2014, 34(5): 107-115.
链接本文:
https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.20140515
或
https://manu60.magtech.com.cn/biotech/CN/Y2014/V34/I5/107
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[16] 王军志. 生物技术药物研究开发和质量控制.第二版.北京:科学出版社, 2007. Wang J ZH. Development and Quality Control of Biopharmaceuticals. 2rd Beijing:Science Press, 2007.
[17] ICH. Pharmaceutical development Q8. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf. Aug, 2009.
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[21] General Chapters: <1046> Cell and gene therapy products. In: United States Pharmacopoeia 34, 2010.
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