Establishing assay sensitivity in QT studies: experience with the use of moxifloxacin in an early phase clinical pharmacology study and comparison with its effect in a thorough QT study

Author:

Shah Rashmi R.,Maison-Blanche Pierre,Duvauchelle Thierry,Robert Philippe,Denis Emmanuel

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference22 articles.

1. Committee for Medicinal Products for Human Use (CHMP) (2005) The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals (CHMP/ICH/423/02) (ICH S7B). European Medicines Agency, London, November 2005. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002841.pdf [Accessed on 15 May 2015]

2. Committee for Medicinal Products for Human Use (CHMP) (2005) ICH E14 Note for guidance on: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (CHMP/ICH/2/04) (ICH E14). European Medicines Agency, London, November 2005. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002879.pdf [Accessed on 15 May 2015]

3. Committee for Medicinal Products for Human Use (CHMP) (2012) ICH Topic E14: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs questions and answers (EMA/CHMP/ICH/310133/2008). European Medicines Agency, London, May 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002878.pdf [Accessed on 15 May 2015]

4. ICH E14 Implementation Working Group (2014) ICH E14 Guideline: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. questions & answers (R2). International Conference on Harmonisation, Geneva, March 2014. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_QAs_R2_Step4.pdf [Accessed on 15 May 2015]

5. Bouvy JC, Koopmanschap MA, Shah RR, Schellekens H (2012) The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies. Clin Pharmacol Ther 91:281–288

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