放射性药物研发的药学研究技术要求探讨

Discussion on pharmaceutical research technology requirements of radiopharmaceutical research and development

放射性药物可为真正意义上的早诊断、早治疗提供新方法、新手段,其市场体量不大,但对生命健康保障的重要性却无可替代。不同于一般化学药物,放射性药物具有一定特殊性,如放射性、时效性、按放射性活度给药、特殊质量控制、有辐射损伤风险等,放射性药物研发应结合其特点进行。我国目前尚无针对放射性药物的药学研究技术指导原则或技术要求,且一般化学药物药学研究技术指导原则(如,ICH Q3A、ICH Q3B、ICH Q3D、ICH M7等)均明确不适用于放射性药物。笔者尝试基于欧洲药物管理局《放射性药物研究指南》,探讨我国此类药物药学研究相关技术要求,以期为该类药物的研发、生产及质量控制提供参考。

Radiopharmaceuticals provide new solutions for early diagnosis and treatments. Although the market capacity of radiopharmaceuticals is relatively limited,this kind of pharmaceuticals has medical significance and irreplaceable value. Different from general chemical drugs,radiopharmaceuticals have certain particularity,such as radioactivity,timeliness, administration according to radioactive activity, special quality control,radiation damage risk,etc. Therefore,the research and development of radiopharmaceuticals should also be carried out in combination with their characteristics. At present,there are no technical guidelines or regulations for the chemical manufacturing control( CMC)research and development( R&D) of radiopharmaceuticals. It is well known that the R&D of radiopharmaceuticals is not carried according to the guiding principles related to that of general chemical drugs( such as ICH Q3A,ICH Q3 B,ICH Q3D,ICH M7,etc.). Here we have introduced some relevant experience of European Medicines Agency to discuss China ’ s technical requirements on CMC R&D of radiopharmaceuticals,in order to provide professional suggestions for industries.