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GaBI Journal-Generics and Biosimilars Initiative Journal最新文献

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Rationalizing FDA guidance on biosimilars — expediting approvals and acceptance 理顺FDA对生物仿制药的指导-加快批准和接受
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/GABIJ.2018.0702.018
Sarfaraz K Niazi
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引用次数: 2
Protein heterogeneity and the immunogenicity of biotherapeutics 生物治疗药物的蛋白质异质性和免疫原性
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/GABIJ.2018.0702.013
R. Jefferis
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引用次数: 4
EU Member States have tools to reduce costs of bestseller biologicals but can they use them 欧盟成员国拥有降低畅销生物制品成本的工具，但它们能否使用这些工具
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-03-15 DOI: 10.5639/GABIJ.2018.0701.002
P. Kurki
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引用次数: 4
Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients 在日本注册的药品主档案分析:旨在稳定供应有效药物成分
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-03-15 DOI: 10.5639/GABIJ.2018.0701.003
Maki Matsuhama, Ryosuke Kuribayashi
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引用次数: 0
The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US 宗教对人类胚胎干细胞监管的影响:英国、德国和美国的比较
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-03-15 DOI: 10.5639/GABIJ.2018.0701.005
Hajaj M Alhomaidan, Ali M Alhomaidan
{"title":"The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US","authors":"Hajaj M Alhomaidan, Ali M Alhomaidan","doi":"10.5639/GABIJ.2018.0701.005","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0701.005","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"49 1","pages":"22-25"},"PeriodicalIF":0.0,"publicationDate":"2018-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91103994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regulations for biotherapeutics approval in Colombia 哥伦比亚生物治疗药物批准条例
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-03-15 DOI: 10.5639/GABIJ.2018.0701.006
J. A. Cortes, Francisco Javier Saura Esteban
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引用次数: 2
Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence 生物仿制药英夫利昔单抗引入胃肠病学护理途径在一个大型急性爱尔兰教学医院:证据背后的故事
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-02-27 DOI: 10.5639/GABIJ.2018.0701.004
G. O’Brien, D. Carrol, Mark Mulcahy, V. Walshe, G. Courtney, S. Byrne
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引用次数: 3
Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution 从Zarxio在美国上市的主要教训:生物仿制药革命的开始
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2017-12-15 DOI: 10.5639/gabij.2017.0604.035
Michael Sarshad
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引用次数: 3
Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies 药物介导的生物仿制药替代-一项针对国家替代政策的全球调查
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2017-12-15 DOI: 10.5639/GABIJ.2017.0604.034
H. Larkin, J. Macdonald, Rebecca S Lumsden
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引用次数: 11
Comment on the non-biological complex drugs paper 非生物复合药物论文评述
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2017-12-15 DOI: 10.5639/gabij.2017.0604.032
K. Bodhinathan
{"title":"Comment on the non-biological complex drugs paper","authors":"K. Bodhinathan","doi":"10.5639/gabij.2017.0604.032","DOIUrl":"https://doi.org/10.5639/gabij.2017.0604.032","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"56 1","pages":"154-156"},"PeriodicalIF":0.0,"publicationDate":"2017-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85824928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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