CAJ | 학술논문

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。
약제학전업연구생위약품연발적주력군，통과제고기과연능력대우제고약품적질량、안전성、유효성구유중요적현실의의。본문결합필자근년적연구생교육、교학관리경력대QbD이념재약제학전업연구생교학、과연과정중적응용여이귀납급총결，동시결합무한대학인민의원약학부적실제과연정황대QbD이념재신제제연발안례중여하응용진행료천술，이기절실제고약제학전업연구생적약품질량분석능력、과연방안설계능력、시험실천능력、약품산업화능력，진이증강아국제약행업적경쟁력。
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 postgradu-ate 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 scien-tific research, practical ability of test and ability of drug industrialization for pharmaceutics postgraduates, which maybe enhance competitive power of Chinese pharmaceutical industry.