Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables

Journal of Biopharmaceutical Statistics

Volumn 18, Issue 3, 2008, Pages 494-501

  Cheng, Bin ^a   Chow, Shein Chung ^b   Burt, David ^c   Cosmatos, Dennis ^c  

^a Howard Hughes Medical Institute   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c PFIZER INC   (United States)

Author keywords

Crossover design; Heteroscedasticity; Maximum of normal variables; Parallel group design; Small sample correction; Thorough QT QTc studies

Indexed keywords

ARTICLE; DOSE TIME EFFECT RELATION; DRUG EFFECT; PARAMETER; PRIORITY JOURNAL; QT INTERVAL; QT PROLONGATION; SIMULATION; STATISTICAL ANALYSIS; ANALYSIS OF VARIANCE; CHEMICALLY INDUCED DISORDER; CROSSOVER PROCEDURE; ELECTROCARDIOGRAPHY; HEART RATE; HUMAN; LONG QT SYNDROME; METHODOLOGY; NORMAL DISTRIBUTION; PATHOPHYSIOLOGY; PHYSIOLOGY; PRACTICE GUIDELINE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; STATISTICAL MODEL; STATISTICS;

NEW DRUG;

ANALYSIS OF VARIANCE; CROSS-OVER STUDIES; DRUGS, INVESTIGATIONAL; ELECTROCARDIOGRAPHY; GUIDELINES AS TOPIC; HEART RATE; HUMANS; LONG QT SYNDROME; MODELS, STATISTICAL; NORMAL DISTRIBUTION; RANDOM ALLOCATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE;

EID: 45849103874     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400802020987     Document Type: Article

References (8)

1. Afonja, B. (1972). The moments of the maximum of correlated normal and t-variates. Journal of the Royal Statistical Society Ser. B 34:251-262.
2. 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 Journal 40:267-271.
3. Hosmane, B., Locke, C. (2005). A simulation study of power in thorough QT/QTc studies and a normal approximation for planning purposes. Drug Information Journal 39:447-455.
4. ICH (2005). ICH E14 Guidance on The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential for Non-Antiarrythmic Drugs. Geneva, Switzerland: International Conference on Harmonisation, May 2005.
5. Malik, M., Camm, A. J. (2001). Evaluation of drug-induced QT interval prolongation. Drug Safety 24:323-351.
6. Patterson, S., Agin, M., Anziano, R. et al. (2005a). 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 Information Journal 39:243-266.
7. Patterson, S. D., Jones, B., Zariffa, N. (2005b). Modelling and interpreting QTc prolongation in clinical pharmacology studies. Drug Information Journal 39:437-445.
8. Temple, R. (2003). Overview of the concept paper, history of the QT/TdP concern; regulatory implications of QT prolongation. Presentations at Drug Information Agency/FDA Workshop. Available at: www.diahome.org.