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本文引用的文献

1
Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors.生物类似重组人粒细胞集落刺激因子的临床安全性。
Expert Opin Drug Saf. 2013 Mar;12(2):235-46. doi: 10.1517/14740338.2013.770472. Epub 2013 Feb 18.
2
Clinical safety of biosimilar recombinant human erythropoietins.生物类似重组人红细胞生成素的临床安全性。
Expert Opin Drug Saf. 2012 Sep;11(5):819-40. doi: 10.1517/14740338.2012.712681. Epub 2012 Aug 13.
3
Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry.质谱法对生物类似药、生物改良药和下一代抗体的表征。
Anal Chem. 2012 Jun 5;84(11):4637-46. doi: 10.1021/ac3002885. Epub 2012 May 14.
4
Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation.促红细胞生成素和非格司亭生物类似药的关键概念与关键问题。来自意大利血液学会、意大利实验血液学会和意大利骨髓移植小组的立场文件。
Haematologica. 2011 Jul;96(7):937-42. doi: 10.3324/haematol.2011.041210.
5
A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study.一项关于生物仿制药依泊汀阿尔法治疗血液透析患者肾性贫血的多层次决定因素、预测因素和临床结局的药物流行病学研究:MONITOR-CKD5 研究的背景和方法。
Intern Emerg Med. 2013 Aug;8(5):389-99. doi: 10.1007/s11739-011-0622-7. Epub 2011 May 18.
6
Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments.监测-GCSF 研究中生物类似物非格司亭降低癌症患者化疗引起的发热性中性粒细胞减少症发生率的更新:方案修正案。
Crit Rev Oncol Hematol. 2011 Mar;77(3):198-200. doi: 10.1016/j.critrevonc.2011.01.006.
7
Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim.MONITOR-GCSF 的背景和方法学:生物类似物粒细胞集落刺激因子非格司亭预防发热性中性粒细胞减少症的多层次决定因素、预测因素和临床结局的药物流行病学研究。
Crit Rev Oncol Hematol. 2011 Mar;77(3):184-97. doi: 10.1016/j.critrevonc.2010.01.014. Epub 2010 Mar 1.
8
Biosimilar therapeutics-what do we need to consider?生物类似药疗法——我们需要考虑什么?
NDT Plus. 2009 Jan;2(Suppl_1):i27-i36. doi: 10.1093/ndtplus/sfn177.
9
The challenge of biosimilars.生物类似药的挑战。
Ann Oncol. 2008 Mar;19(3):411-9. doi: 10.1093/annonc/mdm345. Epub 2007 Sep 14.
10
Biosimilars: how similar or dissimilar are they?生物类似药:它们有多相似或多不同?
Nephrology (Carlton). 2006 Aug;11(4):341-6. doi: 10.1111/j.1440-1797.2006.00594.x.

Biosimilars in 3D: definition, development and differentiation.

作者信息

Abraham Ivo, Sun Diana, Bagalagel Alaa, Altyar Ahmed, Mohammed Abdulaziz, Tharmarajah Soba, MacDonald Karen

机构信息

Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA.

出版信息

Bioengineered. 2013 Jul-Aug;4(4):203-6. doi: 10.4161/bioe.25067. Epub 2013 May 16.

DOI:10.4161/bioe.25067
PMID:23714845
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3728190/
Abstract
摘要