Review of the statistical analysis of the dog telemetry study

Pharmaceutical Statistics

Volumn 10, Issue 3, 2011, Pages 236-249

  Aylott, Mike ^a   Bate, Simon ^b   Collins, Susie ^c   Jarvis, Philip ^d   Saul, Jim ^e  

^a GLAXOSMITHKLINE   (United Kingdom)

^b HUNTINGDON LIFE SCIENCES   (United Kingdom)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^d ASTRAZENECA   (United Kingdom)

^e UK   (United Kingdom)

Author keywords

CV; ECGs; haemodynamics; QT interval; telemetry

Indexed keywords

ARTICLE; DRUG INDUSTRY; NONHUMAN; QT INTERVAL; STATISTICAL ANALYSIS; STUDY DESIGN; TELEMETRY;

ANIMALS; CARDIOVASCULAR SYSTEM; DOGS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DISCOVERY; ELECTROCARDIOGRAPHY; LONG QT SYNDROME; RESEARCH DESIGN; TELEMETRY; TIME FACTORS; TREATMENT OUTCOME; VITAL SIGNS;

EID: 79956088478     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.454     Document Type: Article

References (31)

1. ICH S7A Guideline: Safety Pharmacology Studies for Human Pharmaceuticals, July 2001.
2. ICH S7B Guideline: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals, October 2005.
3. Ollerstam A, Persson AH, Visser SAG, Fredriksson JM, Forsberg T, Nilsson LB, Eklund G, Wiklund SJ, Gabrielsson J, Duker G, Al-Saffara A,. A novel approach to data processing of the QT interval response in the conscious telemetered beagle dog. Journal of Pharmacological and Toxicological Methods 2007; 55: 35-48. (Pubitemid 46048669)
4. Chiang AY, Smith WC, Main BW, Sarazan RD,. Statistical power analysis for hemodynamic cardiovascular safety pharmacology studies in beagle dogs. Journal of Pharmacological and Toxicological Methods 2004; 50: 121-130. (Pubitemid 39286324)
5. Miyazaki H, Watanabe H, Kitayama T, Nishida M, Nishi Y, Sekiya K, Suganami H, Yamamoto K,. QT PRODACT: sensitivity and specificity of the canine telemetry assay for detecting drug-induced QT interval prolongation. Journal of Pharmacological Sciences 2005; 99: 523-529. (Pubitemid 44618152)
6. Chaves AA, Zingaro GJ, Yordy MA, Bustard KA, O'Sullivan S, Galijatovic-Idrizbegovic A, Schuck H, Christian DB, Hoe CM, Briscoe RJ,. A highly sensitive canine telemetry model for detection of QT interval prolongation: studies with moxifloxacin, haloperidol and MK-499. Journal of Pharmacological and Toxicological Methods 2007; 56: 103-114. (Pubitemid 47376969)
7. Chiang AY, Bass AS, Cooper MM, Engwall MJ, Menton RG, Thomas K,. ILSI-HESI cardiovascular safety subcommittee dataset: an analysis of the statistical properties of QT interval and rate-corrected QT interval (QTc). Journal of Pharmacological and Toxicological Methods 2007; 56: 95-102. (Pubitemid 47375129)
8. Klumpp A, Trautmann T, Markert M, Guth B,. Optimizing the experimental environment for dog telemetry studies. Journal of Pharmacological and Toxicological Methods 2006; 54: 141-149. (Pubitemid 44293423)
9. Sethuraman V, Sun Q,. Impact of baseline ECG collection on the planning, analysis and interpretation of 'thorough' QT trials. Pharmaceutical Statistics 2009; 8: 113-124.
10. Bazett HC,. An analysis of the time-relations of electrocardiograms. Heart 1920; 7: 353-370.
11. Fridericia LS,. Die systolendauer im electrokardiogramm bei normalen menschen und bei herzkranken. Acta Medica Scandinavica. 1920; 53: 469-486.
12. Chiang AY, Holdsworth DL, Leishman DJ,. A one-step approach to the analysis of the QT interval in conscious telemeterized dogs. Journal of Pharmacological and Toxicological Methods 2006; 54: 183-188. (Pubitemid 44404073)
13. Watanabe H, Miyazaki H,. A new approach to correct the QT interval for changes in heart rate using a nonparametric regression model in beagle dogs. Journal of Pharmacological and Toxicological Methods 2006; 53: 234-241. (Pubitemid 44275061)
14. Toyoshima S, Kanno A, Kitayama T, Sekiya K, Nakai K, Haruna M, Mino T, Miyazaki H, Yano K, Yamamoto K,. QT PRODACT: in vivo QT assay in the conscious dog for assessing the potential for QT interval prolongation by human pharmaceuticals. Journal of Pharmacological Sciences 2005; 99: 459-471. (Pubitemid 44618147)
15. Williams EJ,. Experimental designs balanced for the estimation of residual effects of treatments. Australian Journal of Scientific Research Series A 1949; 2: 149-168.
16. Bate ST, Jones B,. A review of uniform cross-over designs. Journal of Statistical Planning and Inference 2008; 138: 336-351.
17. Hsu SU,. Multiple Comparisons: Theory and Methods. Chapman and Hall: London, 1996, pp. 175-180.
18. Littell RC, Pendergast J, Natarajan R,. Tutorial in Biostatistics: modelling covariance structure in the analysis of repeated measures data. Statistics in Medicine 2000; 19: 1793-1819. (Pubitemid 30436064)
19. Kenward MG, Roger JH,. Small sample inference for fixed effects estimators from restricted maximum likelihood. Biometrics 1997; 53: 983-997. (Pubitemid 27391027)
20. Jones B, Kenward MG,. 2003. Design and Analysis of Cross-over Trials (2nd edn). Chapman and Hall: London.
21. Lin YL, Kung MF,. Magnitude of QT prolongation associated with a higher risk of Torsades de Pointes. Pharmacoepidemiology and Drug Safety 2009; 18: 235-239.
22. Goldenberg I, Moss AJ, Zareba W,. Sudden cardiac death without structural heart disease: update on the long QT and Brugada syndromes. Current Cardiology Reports 2005; 7: 349-356. (Pubitemid 41419350)
23. Bjerregaard P, Gussak I,. Short QT syndrome. Annals of Noninvasive Electrocardiology 2005; 10: 436-440. (Pubitemid 43942703)
24. Van de Water A, Verheyen J, Xhonneux R, Reneman RS,. An improved method to correct the QT interval of the electrocardiogram for changes in heart rate. Journal of Pharmacological Methods 1989; 22: 207-217. (Pubitemid 19275446)
25. Raunig D, Depasquale MJ, Huang CH, Winslow R, Fossa AA,. Statistical analysis of QT interval as a function of changes in RR interval in the conscious dog. Journal of Pharmacological and Toxicological Methods 2001; 46: 1-11. (Pubitemid 34260890)
26. Westfall PH, Tobias RD, Rom D,. Multiple Comparisons and Multiple Tests Using the SAS Sysem, Cary, NC: SAS Institute Inc., 1999.
27. Snedecor GW, Cochran WG,. Statistical Methods (8th edn). Iowa State University Press: Ames, Iowa, 1989.
28. Williams DA,. A test for differences between treatment means when several dose levels are compared with a zero dose control. Biometrics 1971; 27: 103-117.
29. Williams DA,. The comparison of several dose levels with a zero dose control. Biometrics 1972; 28: 519-531.
30. Holzgrefe HH, Cavero I, Gleason CR, Warner WA, Buchanan LV, Gill MW, Burkett DE, Durham SK,. Novel probabilistic method for precisely correcting QT interval for heart rate in telemetered dogs and cynomolgus monkeys. Journal of Pharmacological and Toxicological Methods 2007; 55: 159-175. (Pubitemid 46227991)
31. Jones B, Jarvis P, Lewis AJ, Ebbutt AF,. Trial to assess equivalence: the importance of rigorous methods. British Medical Journal 1996; 313: 36-39. [Corrections. British Medical Journal. 1996; 313:550.] (Pubitemid 26229889)