Author:
Ferber Georg,Johannesen Lars
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Reference42 articles.
1. Committee for Proprietary Medicinal Products. Points to consider: the assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products (CPMP/986/96). London: EMEA, 1997 Dec 17 [online]. http://www.fda.gov/ohrms/dockets/ac/03/briefing/pubs/cpmp.pdf . Accessed 26 Oct 2015.
2. International Conference on Harmonisation: ICH Topic E 14: The Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. 2005. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf . Accessed 26 Oct 2015.
3. Patterson S, Agin M, Anziano R, et al. Investigating drug-induced QT and QTc prolongation in the clinic: a review of statistical design and analysis considerations: report from the Pharmaceutical Research and Manufacturers of America QT statistics expert team. Drug Inf J. 2005;39:243–66.
4. Eaton ML, Muirhead RJ, Mancuso JY, et al. A confidence interval for the maximal mean QT interval change caused by drug effect. Drug Inf J. 2006;40:267–71.
5. Boos DD, Hoffman D, Kringle R, et al. New confidence bounds for QT studies. Stat Med. 2007;26:3801–17.