Can non-clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium

Author:

Park Eunjung1,Gintant Gary A2,Bi Daoqin1,Kozeli Devi1,Pettit Syril D3,Pierson Jennifer B3ORCID,Skinner Matthew4,Willard James1,Wisialowski Todd5,Koerner John1,Valentin Jean-Pierre6

Affiliation:

1. Center for Drug Evaluation and Research; US FDA; Silver Spring MD USA

2. Department of Integrative Pharmacology; AbbVie; North Chicago IL USA

3. HESI; Washington DC USA

4. Drug Safety and Metabolism; AstraZeneca; Macclesfield Cheshire UK

5. Drug Safety Research and Development; Pfizer; Groton CT USA

6. Non-Clinical Development; UCB-Biopharma SPRL; Braine-l'Alleud Belgium

Publisher

Wiley

Subject

Pharmacology

Reference60 articles.

1. The Concise Guide to Pharmacology 2017/18: Voltage-gated ion channels;Alexander;Br J Pharmacol,2017

2. Diagnostic tests 2: predictive values;Altman;Br Med J,1994a

3. Diagnostic tests 1: sensitivity and specificity;Altman;Br Med J,1994b

4. QT PRODACT: in vivo QT assay with a conscious monkey for assessment of the potential for drug-induced QT interval prolongation;Ando;J Pharmacol Sci,2005

5. International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs;Anonymous;Fed Regist,2005a

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