摘要
以DNA重组技术为核心的现代生物技术是国际上优先发展的高技术领域之一。以基因工程技术为核心的生物药物已形成一个高新技术产业。利益驱使很多科研单位和企业投入大量资金到基因工程药物的开发中来。在基因工程制药选题立项时应首先考虑产品市场风险、研制过程中的技术风险和国家政策法规的修改所带来的风险;其次,在药学研究、临床前药理药效研究、临床研究、资料申报的具体过程中,要根据产品的具体特性确定好实验方案、工作计划和合作单位,并按药品注册管理办法的要求作好每一阶段的具体工作。就基因工程药物研究过程中的实际问题阐述了一些经验,希望对业内同仁有所帮助。
Modem biotechnology with DNA recombination as the very core has precedence over the hightech region. Biopharmaceuticals based on gene-engineering is now one of the major contributors in hi-tech industry market. Driven by the big profit in this huge market, large amount of money has been invested by institutions and pharmaceutical companies. But first of all, the project selection leader must be forethought of the following risks： the changing market, insurmountable technology problems and policy varieties; further more, a detailed project management must be considered during the whole process of drug development, such as preclinical research, clinical trial plan, and file application, in most of the cases, several departments have to work together for a comprehensive project, such as experiment planning, work schedule and good collaboration. All these works must follow the proposal of registration according to the SFDA regulation. Some personal perspectives and experience our colleagues during research and development of biopharmaceuticals were Shared, hoping that these may give some guide and suggestions.
出处
《中国生物工程杂志》
CAS
CSCD
北大核心
2005年第10期93-96,共4页
China Biotechnology
基金
国家"十五""863"计划(2001AA215401)
重大专项(2003AA2Z3360)资助
