WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products
Author:
Affiliation:
1. Department of Essential Medicines and Health Products, Norms and Standards for Biologicals; World Health Organization; Geneva Switzerland
2. The Farthings; Kingston upon Thames; UK
Publisher
Wiley
Subject
History and Philosophy of Science,General Biochemistry, Genetics and Molecular Biology,General Neuroscience
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1111/nyas.13434/fullpdf
Reference45 articles.
1. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks;Hussaarts;Ann. N.Y. Acad. Sci.,2017
2. International standardization of biological products by the League of Nations;McCoy;Am. J. Public Health Nations Health,1936
3. Health Committee of the League of Nations;Nature,1938
4. WHO Expert Committee on Biological Standardization 1948 Report of the second session London
Cited by 18 articles. 订阅此论文施引文献 订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
1. Bridging the gap: The future of biosimilars regulations;Human Vaccines & Immunotherapeutics;2024-06-17
2. A genome‐edited N. benthamiana line for industrial‐scale production of recombinant glycoproteins with targeted N‐glycosylation;Biotechnology Journal;2023-10-15
3. Emerging themes and factors influencing the prices of biotherapeutics;World Medical & Health Policy;2023-05-02
4. Trends in industrialization of biotherapeutics: a survey of product characteristics of 89 antibody-based biotherapeutics;mAbs;2023-03-30
5. An Institutional Guide for Formulary Decisions of Biosimilars;Hospital Pharmacy;2022-11-29
1.学者识别学者识别
2.学术分析学术分析
3.人才评估人才评估
"同舟云学术"是以全球学者为主线，采集、加工和组织学术论文而形成的新型学术文献查询和分析系统，可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容，当前同舟云学术共收录了国内外主流学术期刊6万余种，收集的期刊论文及会议论文总量共计约1.5亿篇，并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询！咨询电话：010-8811{复制后删除}0370
www.globalauthorid.com
TOP
Copyright © 2019-2024 北京同舟云网络信息技术有限公司 京公网安备11010802033243号 京ICP备18003416号-3