A Comparison of Several Methods For Analyzing Data from Thorough QT Studies

REFERENCES

• Boos , D. D. , Hoffman , D. , Kringle , R. , Zhang , J. ( 2007 ). New confidence bounds for QT studies . Stat. Med. 26 : 3801 – 3817 .
   PubMed Web of Science ®Google Scholar
• Cheng , B. , Chow , S.-C. , Burt , D. , Cosmatos , D. ( 2008 ). Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables . J. Biopharm. Stat. 18 : 494 – 501 .
   PubMed Web of Science ®Google Scholar
• Eaton , M. L. , Muirhead , R. J. , Mancuso , J. Y. , Kolluri , S. ( 2006 ). A confidence interval for the maximal mean QT interval change caused by drug effect . Drug Information J. 40 : 267 – 271 .
   Google Scholar
• Food and Drug Administration. (2005). The clinical evaluation of QT/QTc Interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs. ICH, E14. May 25. Available at http://www.fda.gov/downloads/RegulatoryInformation/ Guidances/UCM129357.pdf
   Google Scholar
• Hutmacher , M. M. , Chapel , S. , Agin , M. A. , Fleishaker , J. C. , Lalonde , R. L. ( 2008 ). Performance characteristics for some typical QT study designs under the ICH E-14 guidance . J. Clini. Pharmacol. 48 : 215 – 224 .
   PubMed Web of Science ®Google Scholar