行业分析 |
|
|
|
|
从国际非专利名称纵观全球生物药发展 |
曹萌1,2,赵宇豪1,3,郭中平1,*() |
1 国家药典委员会 北京 100061 2 上海药品审评核查中心 上海 201203 3 上海市食品药品检验所 上海 201203 |
|
A Review of the Global Bio-Therapeutics Development Process from the Perspective of International Nonproprietary Names |
CAO Meng1,2,ZHAO Yu-hao1,3,GUO Zhong-ping1,*() |
1 Chinese Pharmacopoeia, Beijing 100061,China 2 Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China 3 Shanghai Institute for Food and Drug Control, Shanghai 201203, China |
[1] |
郭中平, 徐莉 . 我国生物制品通用名命名原则的修订. 中国生物工程杂志, 2017,37(8):110-118.
|
|
Guo Z P, Xu L . Revision of the general policies of nomenclature for biological products in China. China Biotechnology, 2017,37(8):110-118.
|
[2] |
徐莉, 郭中平 . 国内外生物制品通用名命名体系的比较与分析. 中国药事, 2018,32(4):502-509.
|
|
Xu L, Guo Z P . Comparison and analysis of generic naming system for biological products at home and abroad. Chinese Pharmaceutical Affairs, 2018,32(4):502-509.
|
[3] |
曹萌, 王冲, 付秋雁 , 等. 新时代下药品监管模式的探讨与实践. 上海医药, 2018,39(3):5-9,13.
|
|
Cao M, Wang C, Fu Q Y , et al. Discussion and practice of drug regulation mode in new era. Shanghai Medical & Pharmaceutical Journal, 2018,39(3):5-9,13.
|
[4] |
徐莉, 郭中平 . WHO国际非专利药品名称的申请. 中国新药杂志, 2019,28(3):257-262.
|
|
Xu L, Guo Z P . Application for WHO international nonproprietary name for pharmaceutical substances. Chinese Journal of New Drugs, 2019,28(3):257-262.
|
[5] |
World Health Organization. International Nonproprietary Names (INN) programme. [2019-01-10]. https://www.who.int/medicines/services/inn/en/.
|
[6] |
国家药典委员会. 中国药品通用名称. 北京: 化学工业出版社, 2014: 1408.
|
|
Chinese Pharmacopoeia Commission. China approved drug names. Beijing: Chemical Industry Press, 2014: 1408.
|
[7] |
Department E M a H P E . Guidance on the use of International Nonproprietary Names (INNs) for pharmaceutical substances. Geneva: World Health Organization, 2017: 5-51.
|
[8] |
World Health Organization. Lists of recommended and proposed INNs. [2019-03-10]. https://www.who.int/medicines/publications/druginformation/innlists.
|
[9] |
郭中平 . 生物药通用名命名的探讨. 中国新药杂志, 2014,23(20):2394-2398.
|
|
Guo Z P . Discussion on the naming of biological products. Chinese Journal of New Drugs, 2014,23(20):2394-2398.
|
[10] |
Programme I N N I . Nomenclature schemes for advanced therapies. INN working doc.Geneva: World Health Organization, 2017: 2-5.
|
[11] |
Programme I N N I . INN for biological and biotechnological substances (a review). Geneva: World Health Organization, 2016: 1-69.
|
[12] |
曹萌, 李建平 . CAR-T细胞技术产品欧美监管情况探讨. 中国医药工业杂志, 2018,49(10):1459-1464.
|
|
Cao M, Li J P . Regulations of chimeric antigen receptor T cell products in United States and European Union. Chinese Journal of Pharmaceuticals, 2018,49(10):1459-1464.
|
[13] |
European Medicines Agency. Medicines Search. [2019-01-22]. https://www.ema.europa.eu/en/medicines.
|
[14] |
U S Food and Drug Administration. Search Drugs@FDA. [2019-01-28]. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.
|
[15] |
Jappan Pharmaceuticals and Medical Devices Agency. List of approved products. [2019-01-28]. https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html.
|
[16] |
药品审评中心. 药品数据查询.[2019-3-31]. http://www.nmpa.gov.cn/WS04/CL2043/.
|
|
Center for Drug Evaluation. Drug data query.[2019-3-31]. http://www.nmpa.gov.cn/WS04/CL2043/.
|
[17] |
风云(新康界). 2018年全球药物销售额TOP100 | 排行榜. [2019-04-03]. https://xueqiu.com/6351087572/121555719.
|
|
Fengyun(XKJ0101). Global drug sales TOP100 | rankings. [2019-04-03]. https://xueqiu.com/6351087572/121555719.
|
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
|
Shared |
|
|
|
|
|
Discussed |
|
|
|
|