Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives-Reference-Cited by-同舟云学术

登录注册会员服务联系我们

Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives

Published:2019-02 Issue:2 Volume:8 Page:87-96
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Marshall Scott¹,Madabushi Rajanikanth²,Manolis Efthymios³,Krudys Kevin²,Staab Alexander⁴,Dykstra Kevin⁵,Visser Sandra A.G.⁶

Affiliation:

1. Pharmacometrics, Clinical Pharmacology; Pfizer R&D UK Ltd; Sandwich UK

2. Office of Clinical Pharmacology; Center for Drug Evaluation and Research, US Food and Drug Administration; Silver Spring Maryland USA

3. European Medicines Agency (EMA); London UK

4. Translational Medicine & Clinical Pharmacology; Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach Germany

5. qPharmetra, LLC; Andover Massachusetts USA

6. Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline; Philadelphia Pennsylvania USA

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/psp4.12372/fullpdf

Reference37 articles.

1. Model-based drug development: a rational approach to efficiently accelerate drug development;Milligan;Clin. Pharmacol. Ther.,2013

2. Impact of modeling and simulation: myth or fact?;Allerheiligen;Clin. Pharmacol. Ther.,2014

3. Good practices in model-informed drug discovery and development (MID3): practice, application and documentation;EFPIA MID3 Workgroup;CPT Pharmacometrics Syst. Pharmacol.,2016

4. Getting innovative therapies faster to patients at the right dose: impact of quantitative pharmacology towards first registration and expanding therapeutic use;Nayak;Clin. Pharmacol. Ther.,2018

5. Establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance;Byon;CPT Pharmacometrics Syst. Pharmacol.,2013

Cited by 86 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. The evolution of computational research in a data-centric world;Cell;2024-08

2. Computer Simulation for Effective Pharmaceutical Kinetics and Dynamics: A Review;Current Computer-Aided Drug Design;2024-08

3. A Modern Curriculum for Training Scientists in Model‐Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists;Clinical Pharmacology & Therapeutics;2024-07-16

4. From Plan to Pivot: How Model‐Informed Drug Development Shaped the Dose Strategy of the Zibotentan/Dapagliflozin ZENITH Trials;Clinical Pharmacology & Therapeutics;2024-07-03

5. Disease progression modeling with temporal realignment: An emerging approach to deepen knowledge on chronic diseases;Pharmacology & Therapeutics;2024-07

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