Author:
Malik Marek,Garnett Christine,Hnatkova Katerina,Johannesen Lars,Vicente Jose,Stockbridge Norman
Publisher
Springer Science and Business Media LLC
Reference37 articles.
1. ICHHT Guideline (2005) E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Guidance to industry. Fed Regist 70:61134–61135
2. Zhang J, Machado SG (2008) Statistical issues including design and sample size calculation in thorough QT/QTc studies. J Biopharm Stat 18:451–467
3. Malik M, Garnett CE, Zhang J (2010) Thorough QT studies. Questions and quandaries. Drug Saf 33:1–14
4. Darpo B, Garnett C, Benson CT, Keirns J, Leishman D, Malik M, Mehrotra N, Prasad K, Riley S, Rodriguez I, Sager P, Sarapa N, Wallis R (2014) Cardiac safety research consortium: can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward. Am Heart J 168:262–272
5. Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N (2015) Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase. Clin Pharm Therap 97:326–335
Cited by
15 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