Risk Control Strategy in the Research and Development of 
Pediatric Drugs

亚洲社会药学 ›› 2019, Vol. 14 ›› Issue (3): 110-118.

Risk Control Strategy in the Research and Development of Pediatric Drugs

Tang Ying, Chen Yuwen*

School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China

出版日期:2019-09-20 发布日期:2019-10-12

Risk Control Strategy in the Research and Development of Pediatric Drugs

Tang Ying, Chen Yuwen*

School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China

Online:2019-09-20 Published:2019-10-12
Contact: Chen Yuwen, professor. Major research area: pharmacy administration, new drug research and development, etc. Tel: 024-23986552, E-mail: cywwyc@163.com. E-mail:cywwyc@163.com

摘要/Abstract

摘要： Objective To analyze the risk control strategy in the research and development of pediatric drugs and to provide references for pharmaceutical enterprises to avoid the risks so that they can produce more and much better drugs for children in China. Methods An expert questionnaire and expert interviews were conducted to identify the specific risks and the key factors, and valuable advices were put forward. Results and Conclusion There are four risk factors in the research and development of pediatric drugs. The first is that parents are concerned and they are unwilling to allow their children to participate in drug trial. Secondly, adult drug safety data cannot support pediatric drug study. Thirdly, pediatric drugs often have adverse events. Last, regulations for pediatric drugs clinical trials are not perfect. Some valuable recommendations are provided to control these risks.

关键词: pharmaceutical enterprise, risk management, pediatric drug, drug research and development

Abstract: Objective To analyze the risk control strategy in the research and development of pediatric drugs and to provide references for pharmaceutical enterprises to avoid the risks so that they can produce more and much better drugs for children in China. Methods An expert questionnaire and expert interviews were conducted to identify the specific risks and the key factors, and valuable advices were put forward. Results and Conclusion There are four risk factors in the research and development of pediatric drugs. The first is that parents are concerned and they are unwilling to allow their children to participate in drug trial. Secondly, adult drug safety data cannot support pediatric drug study. Thirdly, pediatric drugs often have adverse events. Last, regulations for pediatric drugs clinical trials are not perfect. Some valuable recommendations are provided to control these risks.

Key words: pharmaceutical enterprise, risk management, pediatric drug, drug research and development

Tang Ying, Chen Yuwen. Risk Control Strategy in the Research and Development of Pediatric Drugs[J]. 亚洲社会药学, 2019, 14(3): 110-118.

Tang Ying, Chen Yuwen. Risk Control Strategy in the Research and Development of Pediatric Drugs[J]. Asian Journal of Social Pharmacy, 2019, 14(3): 110-118.

[1]	Yang Yu, Shi Yu, Hu Rongbo, Tian Lijuan. Research and Enlightenment of EU Drug Risk Management Plan[J]. 亚洲社会药学, 2021, 16(1): 23-30.
[2]	Chen Yuan, Chen Yuwen. Analysis on the Development Strategy of China’s Pharmaceutical Enterprises under the Background of Volume Procurement[J]. 亚洲社会药学, 2020, 15(4): 193-197.
[3]	Wang Wanting, Xing Hua. Application Research of Earned Value Management in New Drug Research and Development Projects[J]. 亚洲社会药学, 2020, 15(1): 16-21.
[4]	Zhao Jianfeng, Zhang Wei, Yu Hai. Reflections on the Management of Preventing Interest Conflict among Pharmacopoeia Members[J]. 亚洲社会药学, 2019, 14(2): 39-44.
[5]	Lian Guiyu, Xu Ruguo. A Study of the Culture Construction of Pharmaceutical Enterprises in China[J]. 亚洲社会药学, 2018, 13(2): 64-68.
[6]	Jin Quanyuan, Lin Xiaohui, Dong Li. Research on Setting up Patent Risk Management System in Medical colleges and universities in China[J]. 亚洲社会药学, 2018, 13(1): 8-15.
[7]	Fu Fei, Zhao Yinghuan. Social Responsibility of Pharmaceutical Enterprises and Consumer Responses: A Relationship Research[J]. 亚洲社会药学, 2018, 13(1): 27-32.
[8]	Alita, Wu Zhi’ang. A Study of the International Collaboration Network in Pharmaceutical Research in the United States [J]. 亚洲社会药学, 2017, 12(4): 131-139.
[9]	. The Application of HACCP System in Drug Distribution[J]. 亚洲社会药学, 2016, 11(1): 37-41.
[10]	ZHANG Xing;LIAN Gui-yu;CHEN Yu-wen. Risk Aversion in New Drug Research and Development Market[J]. , 2014, 9(3): 124-127.

亚洲社会药学

Risk Control Strategy in the Research and Development of Pediatric Drugs

Risk Control Strategy in the Research and Development of Pediatric Drugs

PDF

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 10

编辑推荐

Metrics

本文评价