84
Views
3
CrossRef citations to date
0
Altmetric
Original Articles

Further Discussion on the Design and Analysis of Thorough QTc Clinical Trials: Guest Editors' Notes

&
Pages 493-496 | Published online: 21 Apr 2010

REFERENCES

  • Boos , D. D. , Hoffman , D. , Kringle , R. , Zhang , J. ( 2007 ). New confidence bounds for QT studies . Stat. Med. 26 : 3801 – 3817 .
  • 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 .
  • Dallow , N. S. , Leonov , S. L. , and Roger , J. H. ( 2008 ). Practical usage of O'Brien's OLS and GLS statistics in clinical trials . Pharm. Stat. 7 : 53 – 68 .
  • 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 .
  • Garnett , C. E. , Beasley , N. , Bhattaran , V. A. , Jadhav , P. R. , Madabushi , R. , Stockbridge , N. , Tornee , C. W. , Wang , Y. , Gobburu , J. V. ( 2008 ). Concentration–QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review . J. Clin. Pharmacol. 48 : 13 – 18 .
  • Läuter , J. ( 1996 ). Exact t and F tests for analyzing studies with multiple endpoints . Biometrics 52 : 964 – 970 .
  • Stylianou , A. , Roger , J. , Stephens , K. ( 2008 ). A statistical assessment of QT data following placebo and moxifloxacin dosing in thorough QT studies . J. Biopharm. Stat. 18 : 502 – 516 .
  • Tsong , Y. , Zhong , J. , Chen , W. J. (2008). Validation testing in thorough QT/QTc clinical trials. J. Biopharm. Stat. 18(3):529–541.
  • Tsong , Y. , Zhang , J. , Zhong , J. ( 2009 ). Letter to the editor: Comment on: New confidence bounds for QT studies, by Boos, D. D., Hoffman, D., Kringle, R., Zhang, J., Stat. in Med. 2007, 28:2936–2940 .
  • Zhang , J. ( 2008 ). Testing for positive control activity in a thorough QTc study . J. Biopharm. Stat. 18 : 517 – 528 .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.