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目的为促进和提高紫杉醇新剂型的开发效率,从注册审评角度提出研发建议。方法调研国外成功上市产品的研究思路并总结分析我国紫杉醇改剂型注册申请中常见的问题。结果与结论提出了紫杉醇改剂型研究的整体研究思路,并对于处方工艺筛选、质量研究、稳定性研究、药理毒理和临床研究中需重点关注的问题进行了分析,提出了合理建议。
Objective To promote and improve the development efficiency of new dosage forms of paclitaxel, and to propose research and development proposals from the perspective of registration review. Methods Investigate the research ideas of successful overseas products and summarize and analyze the common problems in the registration application of paclitaxel in China. RESULTS AND CONCLUSIONS The overall research thinking of the paclitaxel modified dosage form research was put forward and the problems needing attention in screening, quality research, stability research, pharmacology and toxicology and clinical research of prescription technology were analyzed and reasonable suggestions were put forward.