Moxifloxacin-induced QTcinterval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study-Reference-Cited by-同舟云学术

Moxifloxacin-induced QTcinterval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study

Published:2015-07-02 Issue:3 Volume:80 Page:446-459
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Morganroth Joel¹,Wang Yaning²,Thorn Michael³,Kumagai Yuji⁴,Harris Stuart⁵,Stockbridge Norman⁶,Kleiman Robert¹,Shah Rashmi⁷

Affiliation:

1. EResearch Technology Inc.; Philadelphia

2. Division of Pharmacometrics; Food and Drug Administration; Silver Spring Maryland

3. Statistical Resources Inc.; Chapel Hill, North Carolina; USA

4. Clinical Research Centre; Kitasato University East Hospital; Sagamihara Japan

5. SeaView Research Inc.; Miami Florida

6. Division of Cardiovascular and Renal Products; Food and Drug Administration; Silver Spring Maryland USA

7. Gerrards Cross; Buckinghamshire UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.12684/fullpdf

Reference38 articles.

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4. Committee for Medicinal Products for Human Use (CHMP) ICH Topic E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers 2012 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002878.pdf

5. ICH E14 Implementation Working Group ICH E14 Guideline: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 2014 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_QAs_R2_Step4.pdf

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