QbD理念在提高药剂学专业研究生科研能力中的应用

Application of Qb D idea in improving scientific research ability of pharmaceutics postgraduate

药剂学专业研究生为药品研发的主力军,通过提高其科研能力对于提高药品的质量、安全性、有效性具有重要的现实意义。本文结合笔者近年的研究生教育、教学管理经历对QbD理念在药剂学专业研究生教学、科研过程中的应用予以归纳及总结,同时结合武汉大学人民医院药学部的实际科研情况对QbD理念在新制剂研发案例中如何应用进行了阐述,以期切实提高药剂学专业研究生的药品质量分析能力、科研方案设计能力、试验实践能力、药品产业化能力,进而增强我国制药行业的竞争力。

As the main force in the process of research and development for drug, the pharmaceutics postgraduates play an important part in improving quality, safety and efficacy of drug. Combing with experiences in recent years of postgraduate education and teaching management, the paper summarizes QbD idea applied to the process of postgraduate teaching and scientific research, and elaborates how to apply QbD idea to the case of research and development for new drug formulation according to practical research and development situation of Department of Pharmacy, Renmin Hospital of Wuhan University. That will be expected to improve quality analysis ability, protocol design ability of scientific research, practical ability of test and ability of drug industrialization for pharmaceutics postgraduates, which maybe enhance competitive power of Chinese pharmaceutical industry.