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GaBI Journal-Generics and Biosimilars Initiative Journal最新文献

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Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures 曲妥珠单抗(CT-P6)生物仿制药在小瓶重构、聚烯烃袋稀释和不同温度下储存后的延长稳定性
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-09-15 DOI: 10.5639/GABIJ.2018.0703.022
V. Vieillard, A. Astier, M. Paul
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引用次数: 8
In vitro analytical and antibiotic comparison of generic moxifloxacin against E. coli and S. aureus bacteria strains 莫西沙星对大肠杆菌和金黄色葡萄球菌的体外分析及抗菌比较
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-09-15 DOI: 10.5639/GABIJ.2018.0703.024
Antistio Alvíz-Amador, Jairo E Mercado Camargo, Marlene Durán-Lengua
{"title":"In vitro analytical and antibiotic comparison of generic moxifloxacin against E. coli and S. aureus bacteria strains","authors":"Antistio Alvíz-Amador, Jairo E Mercado Camargo, Marlene Durán-Lengua","doi":"10.5639/GABIJ.2018.0703.024","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0703.024","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"62 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83988341","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: 1
Quality assessment of biosimilars in Colombia – reducing knowledge gaps 哥伦比亚生物仿制药质量评估——缩小知识差距
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/GABIJ.2018.0702.017
E. Gray, P. Matejtschuk, R. Thorpe
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引用次数: 0
Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2 LY2963016甘精胰岛素和参考甘精胰岛素产品III期试验中患者报告的结局指标:ELEMENT 1和ELEMENT 2
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/GABIJ.2018.0702.012
M. Perez-Nieves, Robyn K. Pollom, R. Duan, S. Kabul, A. DeLozier, P. Kaushik, L. Ilag
{"title":"Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2","authors":"M. Perez-Nieves, Robyn K. Pollom, R. Duan, S. Kabul, A. DeLozier, P. Kaushik, L. Ilag","doi":"10.5639/GABIJ.2018.0702.012","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0702.012","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"35 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74668347","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: 2
Potential changes to the FDA approach to biosimilars have a global impact FDA对生物仿制药方法的潜在变化具有全球影响
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/GABIJ.2018.0702.011
P. Kurki
{"title":"Potential changes to the FDA approach to biosimilars have a global impact","authors":"P. Kurki","doi":"10.5639/GABIJ.2018.0702.011","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0702.011","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"109 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82282695","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: 1
How to realize the potential of off-patent biologicals and biosimilars in Europe? Guidance to policymakers 如何在欧洲实现非专利生物制品和生物仿制药的潜力?对政策制定者的指导
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/GABIJ.2018.0702.014
S. Simoens, C. Pen, N. Boone, F. Breedveld, A. Celano, A. Llombart-Cussac, F. Jørgensen, A. Süle, A. A. Bodegraven, R. Westhovens, J. Cock
{"title":"How to realize the potential of off-patent biologicals and biosimilars in Europe? Guidance to policymakers","authors":"S. Simoens, C. Pen, N. Boone, F. Breedveld, A. Celano, A. Llombart-Cussac, F. Jørgensen, A. Süle, A. A. Bodegraven, R. Westhovens, J. Cock","doi":"10.5639/GABIJ.2018.0702.014","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0702.014","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"191 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75530469","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: 9
What to look forward to in GaBI Journal, 2018, Issue 2 《GaBI杂志》2018年第2期有什么值得期待的
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/GABIJ.2018.0702.010
P. Walson
{"title":"What to look forward to in GaBI Journal, 2018, Issue 2","authors":"P. Walson","doi":"10.5639/GABIJ.2018.0702.010","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0702.010","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"132 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79647094","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
Biosimilar regulation and approval in Jordan 约旦的生物仿制药法规和批准
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/GABIJ.2018.0702.016
Rana Malkawi, Wesal Salem Al Haqaish, Hayel Obeidat
{"title":"Biosimilar regulation and approval in Jordan","authors":"Rana Malkawi, Wesal Salem Al Haqaish, Hayel Obeidat","doi":"10.5639/GABIJ.2018.0702.016","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0702.016","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82404668","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: 1
A call for coherence in EU legislation to promote generics 呼吁欧盟立法一致性以促进仿制药
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/gabij.2018.0702.019
GaBI Journal Editor
{"title":"A call for coherence in EU legislation to promote generics","authors":"GaBI Journal Editor","doi":"10.5639/gabij.2018.0702.019","DOIUrl":"https://doi.org/10.5639/gabij.2018.0702.019","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81625797","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
Regulation of copy biologicals in China 中国仿制生物制品的监管
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-06-15 DOI: 10.5639/gabij.2018.0702.015
GaBI Journal Editor
{"title":"Regulation of copy biologicals in China","authors":"GaBI Journal Editor","doi":"10.5639/gabij.2018.0702.015","DOIUrl":"https://doi.org/10.5639/gabij.2018.0702.015","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"243 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78986821","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: 4
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