Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – ( III ) A Randomized Trial with Interferon Beta‐1a Products

Author:

Florian Jeffry1,Gershuny Victoria1,Sun Qin2,Schrieber Sarah J.3,Matta Murali K.1ORCID,Hazel Anthony1ORCID,Sheikhy Morasa1ORCID,Weaver James L.1,Hyland Paula L.1,Hsiao Cheng‐Hui1,Vegesna Giri1,DePalma Ryan1,Shah Aanchal14,Prentice Kristin14,Sanabria Carlos5,Wang Yow‐Ming2ORCID,Strauss David G.1ORCID

Affiliation:

1. Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Therapeutic Biologics Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

4. Booz Allen Hamilton McLean Virginia USA

5. Spaulding Clinical Research West Bend Wisconsin USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference41 articles.

1. US Food and Drug Administration.Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product (2015). Accessed May 1 2022.

2. US Food and Drug Administration.Guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product (2016). Accessed May 1 2022.

3. Pharmacodynamic biomarkers for biosimilar development and approval: workshop background (2021). Accessed May 1 2022.

4. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

5. G-CSF and GM-CSF in Neutropenia

同舟云学术

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