基于行业指导原则的体内药物分析研究生学位课程——新加坡国立大学的经验与启示

Development of Biopharmaceutical Analysis postgraduate course based on guidance for industry:experiences from the National University of Singapore

课程学习是研究生教育的重要组成部分。由于药品是特殊的商品,受各地法律严格监管,因此,药政法规和行业指导原则应该成为药学教育,特别是研究生教育不可缺少的内容。笔者以新加坡国立大学(National University of Singapore,NUS)研究生学位课程PR5211 Pharmaceutical Analysis IV(PR5211药物分析IV)为例,讨论如何以药政部门颁行的生物分析方法验证的行业指导原则(Guidance for Industry:Bioanalytical Method Validation)为基础,设计体内药物分析的研究生学位课程。此课程以行业指导原则为纲,在真实世界的具体个案中教授药物分析知识,在实景中考查分析技能的应用,特别强调培养学生的终身学习能力,在实践中取得了良好的效果,这样的教育模式值得坚持,并在药学其他研究生课程中推广。

s:Course learning is an essential component of postgraduate education.Due to the unique nature of pharmaceuticals,which are subject to strict legal regulations,industry guidelines should be incorporated into pharmacy education,especially in postgraduate programs.Taking the graduate course(PR5211 Pharmaceutical Analysis IV)at the National University of Singapore(NUS)as an example,this paper discusses how to design a postgraduate course in Biopharmaceutical Analysis based on the guidance for industry:Bioanalytical Method Validation which is issued by regulatory authorities.This course takes industry guidelines as its framework,teaches pharmaceutical analysis knowledge in real-world case studies,and assesses the application of analytical skills in actual scenarios.It particularly emphasizes the cultivation of students'lifelong learning abilities and has achieved good results in practice.This educational model is worth adhering to and promoting in other graduate courses in pharmacy.