中国药业2016，Vol.25Issue(22)：1-4,5,5.
基于抗体生物类似药研发的生物制药共性技术服务平台合作模式研究
Research on Cooperative Model of Service Towards Generic Technology in Biopharmaceutics Based on Biosimilar Monoclonal Antibody
张灿 1董丽1
作者信息
- 1. 沈阳药科大学工商管理学院，辽宁 沈阳 110016
- 折叠
摘要
Abstract
Objective To investigate the role of synergistic coordination in the development of biosimilar drugs,especially in monoclonal antibody-like drug research and development. Methods The cooperative model of R&D enterprise and service platform is analyzed through the content and precautions of the cooperation between the biosimilar drug and the common technical service platform in the registration and declaration phase. Result and Conclusion For the majority of small and medium-sized bio-pharmaceutical R&D enterprises,cooperation with contract research organization is not only a business phenomenon,but also the inevitable choice of modern professional division of labor. After outsourcing,R&D enterprises can focus on their core business,which is more professional,more effec-tive,easier to obtain results,more successful,and to a certain extent reduce costs. This can help small and medium R&D enterprises with reasonable arrangements for R&D work and speed up the registration and declaration.关键词
生物类似药/单克隆抗体/合同研究组织/指导原则Key words
biosimilar drug/monoclonal antibody/contract research organization/guideline分类
医药卫生引用本文复制引用
张灿,董丽..基于抗体生物类似药研发的生物制药共性技术服务平台合作模式研究[J].中国药业,2016,25(22):1-4,5,5.
