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

LIN Haishu

PDF(554 KB)
PDF(554 KB)
Researches in Higher Education of Pharmacy ›› 2024, Vol. 42 ›› Issue (3) : 49-57.

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

Author information +
History +

Abstract

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.

Key words

industry guidelines; Biopharmaceutical Analysis; Bioanalytical Method Validation; real-world assessment; life-long learning

CLC number

O657 / R917

Cite this article

Download Citations
LIN Haishu.
Development of Biopharmaceutical Analysis postgraduate course based on guidance for industry: experiences from the National University of Singapore
. Researches in Higher Education of Pharmacy. 2024, 42(3): 49-57

References

[1] 中华人民共和国教育部. 教育部关于改进和加强研究生课程建设的意见[EB/OL]. (2014-12-05) [2023-08-16]. http://www.moe.gov.cn/srcsite/A22/s7065/201412/t20141205_182992.html.
[2] 中华人民共和国药品管理法[EB/OL]. (2019-08-27) [2024-07-24]. https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/ 20190827083801685.html.
[3] National University of Singapore. MSc and PhD Programmes[EB/OL]. (2019-08-26) [2023-08-16]. https://pharmacy.nus. edu.sg/study/postgraduate-programmes/phd-and-msc-programmes/.
[4] National University of Singapore. MSc (Pharmaceutical Science & Technology) Programme[EB/OL]. (2022-06-01) [2023-08-16]. https://pharmacy.nus.edu.sg/study/postgraduate-programmes/msc-pharmaceutical-science-technology-programme/.
[5] The United States Food and Drug Administration. Bioanalytical method validation - guidance for industry (2001). [EB/OL] (2001-05-23) [2023-08-16]. https://www.federalregister.gov/documents/2001/05/23/01-12908/guidance-for- industry-on-bioanalytical-method-validation-availability.
[6] The United States Food and Drug Administration. Bioanalytical method validation - guidance for industry[EB/OL]. (2018-05-24) [2024-07-24]. https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for- Industry.pdf.
[7] European Medicines Agency. Guideline on bioanalytical method validation[EB/OL]. (2011-07-21) [2023-08-16]. https://www.ema.europa.eu/en/bioanalytical-method-validation.
[8] SHAH, V P. The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation[J]. AAPS J, 2009,9(1): E43–E47.
[9] Vl?ková H, Janák J, Gottvald T, et al. How to address the sample preparation of hydrophilic compounds: Determination of entecavir in plasma and plasma ultrafiltrate with novel extraction sorbents[J]. J Pharm Biomed Anal, 2014,88: 337-344.
[10] 国家药典委员会. 中华人民共和国药典(2020年版)[S]. 北京: 中国医药出版社, 2020.
[11] European Medicines Agency. ICH M10 on bioanalytical method validation. ICH guideline M10 on bioanalytical method validation and study sample analysis [EB/OL]. (2021-07-21) [2023-08-16]. https://www.ema.europa.eu/en/ich-m10- bioanalytical-method-validation.
[12] 林海树, 曹纪亮, 赵伟宁, 等. 走向真实情景的药学专业分析化学类课程考试[J]. 高等药学教育研究, 2024(1): 27-34.

Comments

PDF(554 KB)

Accesses

Citation

Detail

Sections
Recommended

/