Design and conduct of the thorough phase I ECG trial for new bioactive drugs

Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development

Volumn , Issue , 2005, Pages 205-222

  Morganroth, Joel ^a,b  

^a EResearch Technology Inc   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 80051821151     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-1-59259-884-7_11     Document Type: Chapter

References (15)

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2. Committee for Proprietary Medicinal Products (CPMP). Points to consider: The assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products. The European Agency for the Evaluation of Medicinal Products, 17 December 1997.
3. Health Canada. Draft Guidance 'Assessment of the QT prolongation potential of non-Antiarrhythmic drugs.' March 15, 2001 http//www.hc-sh.gc.ca/ hpb-dgps/therapeut/htmleng/guidmain.html
4. Morganroth J. Focus on issues in measuring and interpreting changes in the QTc interval duration. Eur Heart J Supplements 2001;3: K105-K111.
5. Morganroth J, Brown AM, Critz S, Crumb WJ, Kunze DL, Lacerda AE, Lopez H, Variability of the QTc interval: Impact on defining drug effect and low-frequency cardiac event. Am J Cardiol 1993;72: 26B-32B.
6. Morganroth J, Brozovich FV, McDonald JT, Jacobs RA. Variability of the QT measurement in healthy men: With implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia. Am J Cardiol 1991;67:774-776.
7. Malik M, Färbom P, Batchvarov V, et al. Relation between QT and RR intervals is highly individual among healthy subjects: Implications for heart rate correction of the QT interval. Heart 2002;87: 220-228.
8. Haverkamp W, Breithardt G, Camm AJ, et al. The potential for QT prolongation and proarrhythmia by non-Antiarrhythmic drugs: Clinical and regulatory implications. Report on a Policy Conference of the European Society of Cardiology. Cardiovascular Research 2000;47:219-33.
9. Shah RR. The significance of QT interval in drug development. Brit J Clin Pharmacol 2002;54:188-202.
10. Sarapa N, Morganroth J, Couderc J-P, Francom SF, Darpo B, Fleishaker JC, McEnroe JD, Chen WT, Zareba W, Moss AJ. Drug-induced QT prolongation in the electrocardiogram: Ssessment by different recording and measurement methods. Ann Noninvasive Electrocardiol 2004;9:48-57.
11. Priori SG, Schwartz PJ Napoliatano C, et al Risk stratification in the long QT syndrome. N Engl J Med 2003;348:1866-1874.
12. Pratt CM, Ruberg S, Morganroth J, et al. Dose-response relation between terfenadine (Seldane) and the QTc interval on the scalar electrocardiogram: Distinguishing a drug effect from spontaneous variability. Am Heart J 1996;131:472-480.
13. Shah RR. Drug-induced Prolongation of the QT interval: Regulatory Dilemmas and Implications for approval and Labelling of a new Chemical Entity. Fundam Clin Pharmacol 2002;16:147-146.
14. Darpö B. Spectrum of drugs prolonging the QT interval and the incidence of Torsades De Pointes. Eur Heart J 2001;3 (Suppl. K):K70-K80.
15. Funck-Brentano C, Jaillon P. Rate-corrected QT interval: Techniques and limitations. Am J Cardiol 1993;72:17-22.