Letter to the editor: Statistical issues of QT prolongation assessment based on linear concentration modeling by Yi Tsong et al.

Journal of Biopharmaceutical Statistics

Volumn 20, Issue 3, 2010, Pages 689-692

  Wang, Yaning ^a   Garnett, Christine ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYSIS OF VARIANCE; BAYES THEOREM; COMMERCIAL PHENOMENA; EFFECT SIZE; ENVIRONMENT; HEALTH SCIENCE; HUMAN; INFORMATION PROCESSING; LETTER; MATHEMATICAL ANALYSIS; METHODOLOGY; MODEL; ORGANIZATION; POLITICS; PRIORITY JOURNAL; PROBABILITY; PUBLICATION; QT PROLONGATION; RESEARCH; RISK FACTOR; STATISTICAL ANALYSIS; VALIDITY; CHEMICALLY INDUCED DISORDER; DOSE RESPONSE; DRUG EFFECT; ELECTROCARDIOGRAM; HEART ARRHYTHMIA; HEART RATE; NOTE; PATHOPHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; STATISTICAL MODEL; STATISTICS; TIME;

ANTIINFECTIVE AGENT; HETEROCYCLIC COMPOUND; MOXIFLOXACIN; QUINOLINE DERIVATIVE;

ANTI-INFECTIVE AGENTS; ARRHYTHMIAS, CARDIAC; AZA COMPOUNDS; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; ELECTROCARDIOGRAM PATTERN; HEART RATE; HUMANS; LINEAR MODELS; MODELS, STATISTICAL; QUINOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS;

EID: 77951684272     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400903094881     Document Type: Letter

References (10)

1. Berger, R. L., Hsu, J. C. (1996). Bioequivalence trials, intersection-union tests and equivalence confidence interval sets. Stat. Sci. 11:283-302.
2. Boos, D., Hoffman, D., Kringle, R., Zhang, J. (2007). New confidence bounds for QT studies. Stat. Med. 26:3801-3817. (Pubitemid 47307750)
3. Eaton, M. L., Muirhead, R. J., Mancuso, J. Y., Lolluri, S. (2006). A confidence interval for the maximal mean QT interval change due drug effect. Drug Information J. 40:267-271.
4. 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. (Pubitemid 350292272)
5. Holford, N. H., Coates, P. E., Guentert, T. W., Riegelman, S., Sheiner, L. B. (1981). The effect of quinidine and its metabolites on the electrocardiogram and systolic time intervals: Concentration-effect relationships. Br. J. Clin. Pharmacol. 11:187-195.
6. International Conference on Harmonization. (2005). ICH (E14) Guidance. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. International Conference on Harmonization, May, Geneva, Switzerland.
7. Patterson, S., Jones, B. (2005). Bioequivalence and Statistics in Clinical Pharmacology. London: Chapman and Hall, CRC Press.
8. Ring, A., Glomb, P. (2008). Impact of Delayed Effects in the Exposure-Response Analysis of Clinical QT Trials. 2008 FDA/Industry Statistics Workshop, September, Washington, DC.
9. Tsong, Y., Shen, M., Zhong, J., Zhang, J. (2008). Statistical issues of QT prolongation assessment based on linear concentration modeling. J. Biopharm. Stat. 18(3):564-584. (Pubitemid 351891695)
10. Wang, Y. (2008). Simulation Based Evaluation of Concentration-QTc (CQTc) Analysis. 2008 FDA/Industry Statistics Workshop, September, Washington, DC.