Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective
Author:
Publisher
Springer New York
Link
http://link.springer.com/content/pdf/10.1007/978-1-4419-7415-0_2
Reference53 articles.
1. Aarons L, Karlsson MO, Mentre F, Rombout F, Steimer JL, van Peer A (2001) Role of modelling and simulation in phase I drug development. Eur J Pharm Sci 13:115–122
2. Balant LP, Gex-Fabry M (2000) Modelling during drug development. Eur J Pharm Biopharm 50:13–26
3. Barrett JS, Fossler MJ, Cadieu KD, Gastonguay MR (2008) Pharmacometrics: a multidisciplinary field to facilitate critical thinking in drug development and translational research settings. J Clin Pharmacol 48:632–649
4. Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, Duan JZ, Baweja RK, Marroum PJ, Uppoor RS, Rahman NA, Sahajwalla CG, Powell JR, Mehta MU, Gobburu JV (2005) Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J 7:E503–E512
5. Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, Jang SH, Kenna L, Lesko LJ, Madabushi R, Men Y, Powell JR, Qiu W, Ramchandani RP, Tornoe CW, Wang Y, Zheng JJ (2007) Impact of pharmacometric reviews on new drug approval and labeling decisions–a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther 81:213–221
Cited by 5 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. Pharmacokinetic/pharmacodynamic modeling of etoposide tumor growth inhibitory effect in Walker-256 tumor-bearing rat model using free intratumoral drug concentrations;European Journal of Pharmaceutical Sciences;2017-01
2. Can an early phase clinical pharmacology study replace a thorough QT study? Experience with a novel H3-receptor antagonist/inverse agonist;European Journal of Clinical Pharmacology;2016-02-16
3. Model-based clinical drug development in the past, present and future: a commentary;British Journal of Clinical Pharmacology;2014-12-19
4. Modeling of tumor growth in dendritic cell-based immunotherapy using artificial neural networks;Computational Biology and Chemistry;2014-02
5. Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance;CPT: Pharmacometrics & Systems Pharmacology;2013-07
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