Evaluation of Weight Thresholds for Pediatric Patients to Use Adult Dosage of Therapeutic Monoclonal Antibodies

Author:

Yang Nicholas1,Xu Melissa C.2,Yao Zhenling3

Affiliation:

1. University of PennsylvaniaVagelos Program in Life Sciences and Management Philadelphia PA USA

2. The Hill School Pottstown PA USA

3. Janssen Research & Development LLC, Spring House PA USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference35 articles.

1. The therapeutic monoclonal antibody market

2. Antibodies to watch in 2018

3. Three years of paediatric regulation in the European Union

4. US Food and Drug Administration.Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans guidance for industry.https://www.fda.gov/downloads/drugs/guidances/ucm360507.pdf2016. Accessed March 31 2019.

5. European Commission. Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies.https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/2014_c338_01/2014_c338_01_en.pdf.2014. Accessed March 31 2019.

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