Model averaging for robust assessment of QT prolongation by concentration-response analysis
Author:
Affiliation:
1. Uppsala University; Uppsala Sweden
2. Novartis Pharma AG; Basel Switzerland
Publisher
Wiley
Subject
Statistics and Probability,Epidemiology
Reference27 articles.
1. International Conference on Harmonisation E14: guidance on clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs 2005
2. Comparison of QTc data analysis methods recommended by the ICH E14 guidance and exposure-response analysis: case study of a thorough QT study of asenapine;Chapel;Clin Pharmacol Ther,2010
3. Performance characteristics for some typical QT study designs under the ICH E-14 guidance;Hutmacher;J Clin Pharmacol,2008
4. The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies;Bouvy;Clin Pharmacol Ther,2012
5. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review;Garnett;J Clin Pharmacol,2008
Cited by 6 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. Evaluation of model‐integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods;CPT: Pharmacometrics & Systems Pharmacology;2024-08-28
2. Assessment of non-linear mixed effects model-based approaches to test for drug effect using simulated data: type I error and power properties;2024-04-17
3. Comparison of Seven Non-Linear Mixed Effect Model-Based Approaches to Test for Treatment Effect;Pharmaceutics;2023-01-30
4. Assessing Treatment Effects with Pharmacometric Models: A New Method that Addresses Problems with Standard Assessments;The AAPS Journal;2021-05
5. Cardiac risk assessment based on early Phase I data and PK-QTc analysis is concordant with the outcome of thorough QTc trials: an assessment based on eleven drug candidates;Journal of Pharmacokinetics and Pharmacodynamics;2019-10-30
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