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大分子生物药物生物分析方法验证—解读欧洲药品管理局指导原则 被引量：6

Bioanalytical Method Validation for Macromolecules:Interpretation of Guideline of European Medicines Agency
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摘要 本文对生物大分子药物生物分析方法的全面验证、部分验证、交叉验证和真实样品分析等方面进行阐述。 The review covers full validation, partial validation, cross-validation and incurred sample analysis aspects of bioanalytical method for macromolecules.
作者 张双庆 范玉明
机构地区 中国食品药品检定研究院
出处 《国外医药（抗生素分册）》 CAS 2012年第5期199-203,共5页 World Notes on Antibiotics
基金 人力资源和社会保障部留学人员科技活动择优项目资助
关键词 生物大分子药物 生物分析方法 验证 macromolecule bioanalytical method validation
分类号 Q5 [生物学—生物化学]
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参考文献10

  • 1Garofolo F, Michon J,Leclaire V,et al. US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium[J]. Bioanalysis, 2012,4(3): 231.
  • 2Kelley M, DeSilva B. Key elements of bioanalytical method validation for macromolecules [J]. AAPS J,2007, 9(2): E156.
  • 3Viswanathan CT, Bansal S,Booth B,et al. Quantitative bioanalytical methods validation and implementation: bestpractices for chromatographic and ligand binding assays[J]. Pharm Res,2007,24(10): 1962.
  • 4Savoie N, Garofolo F, van Amsterdam P,et al. 2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance [J]. Bioanalysis,2010, 2(12): 1945.
  • 5Smolec J,DeSilva B, Smith W, et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies[J]. Pharm Res, 2005,22(9): 1425.
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同被引文献41

  • 1郝琨,柳晓泉,王广基.临床前毒代动力学研究进展[J].中国药科大学学报,2004,35(3):195-199. 被引量：12
  • 2刘昌孝.新药安全性评价中的毒代动力学研究[J].毒理学杂志,2007,21(4):275-276. 被引量：3
  • 3张海艇,刘姝,刘兆平.GLP试验总结报告书稽查(Study Audit)要点[J].毒理学杂志,2007,21(4):290-291. 被引量：2
  • 4郑维义,陈拯民,张雪峰,等.毒代动力学研究在新药开发中的的意义[J].中国药理学与毒理学杂志,2013,27(3):508.
  • 5Cayen MN. Considerations in the design of toxicokinetic programs [J]. Toxicol Pathol, 1995, 23 ( 2 ) : 148-157.
  • 6OECD. OECD guideline for the testing of chemicals: 417 toxicokinetics [S]. 2010.
  • 7CDE.药物毒代动力学研究技术指导原则[EB/OL]. [2014-05-13]. http://www.ede.org.en/zdyz. do?method=largePage&id= 190.
  • 8Landrum PF, Chapman PM, Neff J, et al. Influence of exposure and toxicokinetics on measures of aquatic; toxicity for organic contaminants: a case study review [J]. Integr Environ Assess Manag, 2013, 9 ( 2 ) : 196-210.
  • 9Ieiri I. Pharmacokinetics and pharmacodynamics of anti- diabetic drugs-from the viewpoints of drug transporters and metabolic enzymes [J]. Nihon Rinsho, 2015, 73 (3) : 358-362.
  • 10Diehl KH, Hull R, Morton D, et al. A good practice guide to the administration of substances and removal of blood, including routes and volumes[J]. J Appl Toxicol, 2001, 21 C1) : 15-23.

引证文献6

二级引证文献8

国外医药（抗生素分册）
2012年 第5期

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