参考文献:
[1] 国家药品监督管理局药品审评中心“药物免疫原性研究技术指导原则”,2021年3月
[2] Ulitzka M., Carrara S. C., Grzeschik J., et al. Engineering therapeutic antibodies for patient safety: tackling the immunogenicity problem[J]. Protein Engineering Design and Selection, 2020: 33
[3] Singh, Surjit, et al. "Monoclonal antibodies: a review." Current clinical pharmacology 13.2 (2018): 85-99.
[4] <1106> Immunogenicity Assays - Design and Validation of Immunoassays to Detect Anti-Drug Antibodies
[5] Michael Ulitzka, Stefania Carrara, Julius Grzeschik, Henri Kornmann, Björn Hock, Harald Kolmar, Engineering therapeutic antibodies for patient safety: tackling the immunogenicity problem, Protein Engineering, Design and Selection, Volume 33, 2020, gzaa025, https://doi.org/10.1093/protein/gzaa025
[6] Guidance for Industry Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research, Center for Veterinary Medicine. May 2018.
[7] Draft ICH Guideline M10-Bioanalytical Method Validation (EMEA/CHMP/EWP/172948/2019). March 2019
[8] EMA Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009), adopted 21 July 2011
[9] Gunn GR, Sealey DC, Jamali F,Meibohm B,Ghosh S,Shankar G. From the bench to clinicalpractice:understanding the challenges and uncer⁃tainties in immunogenicity testing for biopharma⁃ceuticals[J]. Clin Exp Immunol,2016,184(2):137-146.
[10] 邵雪,洛文靖,王海学,等.可溶性靶点分子对生物制品抗药抗体桥连法检测的挑战和应对策略[J].中国药理学与毒理学杂志, 2019, 33(11):6.DOI:10.3867/j.issn.1000-3002.2019.11.011.