纳米药物质量控制研究技术指导原则(试行)(国家药审中心通告2021年第35号) . ... ... ...

2021-8-31 18:30| 发布者: 中医天地| 查看: 926| 评论: 0|来自: 国家药监局药物评审中心(CDE)

摘要: 本指导原则在参考国内外已上市纳米药物的相关信息、相关指导原则、监管机构或行业协会的研讨报告、科研文献等的基础上,结合我国纳米药物研发现状而起草,旨在为纳米药物的质量控制研究提供技术指导 ... ... ... ...


五、参考文献

[1] FDA. Guidance for Industry: Considering Whether an FDARegulated Product Involves the Application of Nanotechnology.2014.

[2] FDA. Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterialsdraft. 2017.

[3] FDA. Nanotechnology: A report of the U.S. Food and Drug Administration Nanotechnology Task Force2007.

[4] FDA. Guidance for Industry: Liposome Drug Products Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation. 2002.

[5] US National Institutes of Health Campus. Report on the 2016 Global Summit on Regulatory Science (GSRS16): Nanotechnology Standards and Applications [EB/OL]. 2016.

[6] EMA. Surface coatings: general issues for consideration regarding  parenteral administration of coated nanomedicine products. 2013.

[7] EMA. Data requirements for intravenous iron-based nanocolloidal products developed with reference to an innovator medicinal product. 2015.

[8] EMA. Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product. 2013.

[9] EMA. Development of block-copolymer-micelle medicinal products. 2014.

[10] MHLW. Reflection paper on nucleic acids (siRNA)-loaded nanotechnology-based drug products. 2016.

[11] MHLW. Guideline for the Development of Liposome Drug Products. 2016.

[12] Nanomedicine Characterisation Laboratory. Assay Cascade.

http://www.euncl.eu/about-us/assay-cascade.

[13] NMPA.化学药品注射剂仿制药(特殊注射剂)质量和疗效一致性评价技术要求. 2020.

[14] NMPA.盐酸多柔比星脂质体注射液仿制药研究技术指导原则(试行). 2020.

[15] Taha MS, Padmakumar S, Singh A, et al. Critical quality attributes in the development of therapeutic nanomedicines toward clinical translation. Drug delivery and translational research. 2020, 10 (3): 766-790.

[16] Tyner KM, Zheng N, Choi S, et al. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities. The AAPS journal. 2017, 19 (4): 1071-1083.

[17] Crist RM, Grossman JH, Patri AK, et al. Common pitfalls in nanotechnology: lessons learned from NCI's Nanotechnology Characterization Laboratory. Integrative Biology. 2013, 5 (1): 66-73.

[18] Rawal M, Singh A, Amiji MM. Quality-by-Design Concepts to Improve Nanotechnology-Based Drug Development. Pharm Res. 2019, 36 (11): 153.

[19] Pallotta A, Boudier A, Creusot B, et al. Quality control of gold nanoparticles as pharmaceutical ingredients. Int J Pharm. 2019, 569: 118583.

[20] Ansar SM, Mudalige T. Direct and simultaneous determination of intra-liposomal and external sulfate in liposomal doxorubicin formulations by capillary electrophoresis/inductively coupled

plasma-tandem mass spectrometry (CE/ICP-MS/MS). Int J Pharm. 2019; 561: 283-288.

[21] Coty J-B, Vauthier C. Characterization of nanomedicines: A reflection on a field under construction needed for clinical translation success. J Control Release. 2018, 275: 254-268.

[22] Varenne F, Hillaireau H, Bataille J, et al. Application of validated protocols to characterize size and zeta potential of dispersed materials using light scattering methods. Colloid Surface A, 2019, 560, 418-425.

[23] D'Souza S. A review of in vitro drug release test methods for nano-sized dosage forms. Adv. Pharm., 2014, 2014 (2), 1-12.

[24] Fontana F, Figueiredo P, Zhang P, et al. Production of pure drug nanocrystals and nano co-crystals by confinement methods. Adv. Drug Deliv. Rev. 2018, 131, 3-21.20

六、附录

纳米药物质量控制研究技术指导原则(试行)(国家药审中心通告2021年第35号) .

纳米药物质量控制研究技术指导原则(试行)(国家药审中心通告2021年第35号) .

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