放射性同位素标记药物物质平衡及生物转化临床研究伦理审查专家共识

缪丽燕, 汪秀琴, 徐溢涛, 张华, 马晟, 边诣聪, 邵凤, 黄旭, 朱雪松, 章斌, 孙鲁宁

中国药学杂志 ›› 2020, Vol. 55 ›› Issue (19) : 1649-1652.

PDF(2867 KB)
PDF(2867 KB)
中国药学杂志 ›› 2020, Vol. 55 ›› Issue (19) : 1649-1652. DOI: 10.11669/cpj.2020.19.017
论著

放射性同位素标记药物物质平衡及生物转化临床研究伦理审查专家共识

  • 缪丽燕1,2, 汪秀琴3, 徐溢涛1, 张华1,2, 马晟1,2, 边诣聪1,2, 邵凤3, 黄旭3, 朱雪松1, 章斌1, 孙鲁宁3
作者信息 +
文章历史 +

引用本文

导出引用
缪丽燕, 汪秀琴, 徐溢涛, 张华, 马晟, 边诣聪, 邵凤, 黄旭, 朱雪松, 章斌, 孙鲁宁. 放射性同位素标记药物物质平衡及生物转化临床研究伦理审查专家共识[J]. 中国药学杂志, 2020, 55(19): 1649-1652 https://doi.org/10.11669/cpj.2020.19.017
中图分类号: R052   

参考文献

[1] NATALIA P, LIN X, CHANDRA P. Radiolabeled absorption, distribution, metabolism, and excretion studies in drug development: why, when, and how?. Chem Res Toxicol, 2012,25(3):513-531.
[2] NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA). The Guidance on Non-clinical Pharmacokinetic Study (药物非临床药代动力学研究技术指导原则). (2014-05-13) . http://www. cde. org. cn/zdyz. do?method=largePage&id=21e45c8c5bacf662.
[3] SWART P, LOZACH F,SIMON M, et al. The impact of early human data on clinical development: there is time to win . Drug Discov Today, 2016, 21(6):873-879.
[4] NIJENHUIS C M, SCHELLENS J H M, BEIJNEN J H. Regulatory aspects of human radiolabeled mass balance studies in oncology: concise review . Drug Metab Rev, 2016, 48(2):266-280.
[5] EUROPEAN MEDICINES AGENCY (EMA). Guideline on the investigation of drug interactions, Committee for Human Medicinal Products . (2013-01-01) . https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions-revision-1_en.pdf.
[6] GB18871-2002, Basic Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources. 2002.
[7] STATE COUNCIL OF THE PRC. Regulations on safety of radioactive waste management. (2011-12-20) . http://www.gov.cn/zhengce/content/2011-12/29/content_4655.htm.
[8] FOOD AND DRUG ADMINISTRATION(FDA). Code of Federal Regulations (CFR)-Title 21-Food and Drugs, Part 361.1. Radioactive drugs for certain research uses . FDA, (2019-04-01) . https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=361&showFR=1. 2019-04-01.
[9] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION(ICRP). Radiological Protection in Biomedical Research . Oxford: Pergamon Press, 1993:1-14.

基金

国家十三五“重大新药创制”科技重大专项资助(2017ZX09304021)
PDF(2867 KB)

Accesses

Citation

Detail

段落导航
相关文章

/