Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020
Author:
Affiliation:
1. Office of Clinical Pharmacology, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1853
Reference35 articles.
1. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000‐2012;Sacks LV;JAMA,2014
2. Postmarketing drug dosage changes of 499 FDA‐approved new molecular entities, 1980‐1999;Cross J;Pharmacoepidemiol Drug Saf,2002
3. Pediatric ontogeny: moving from translational science to drug development;Burckart GJ;J Clin Pharmacol,2019
4. The revolution in pediatric drug development and drug use: therapeutic orphans no more;Burckart GJ;J Pediatr Pharmacol Ther,2020
5. Failed pediatric drug development trials;Momper JD;Clin Pharmacol Ther,2015
Cited by 13 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. Population Pharmacokinetics (PopPK) Support for Pediatric Dosing of Biological Products;The Journal of Clinical Pharmacology;2024-08-16
2. Model-informed drug development in pediatric, pregnancy and geriatric drug development: States of the art and future;Advanced Drug Delivery Reviews;2024-08
3. Assessment of Dosing Strategies for Pediatric Drug Products;Clinical Pharmacology & Therapeutics;2024-03-17
4. Developing Therapy for Every Kid With Cancer – Summary of a Scientific Session at the 2023 ASCPT Meeting;Clinical Pharmacology & Therapeutics;2023-11-24
5. Obesity Considerations in Pediatric Drug Development, 2016–2021;The Journal of Clinical Pharmacology;2023-11
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