International Conference on Harmonization: Guidance on E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs; Availability. Notice
Food and Drug Administration, Health and Human Services
Food and Drug Administration, Health and Human Services. International Conference on Harmonization: guidance on E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs; availability. Notice. Fed Regist. 2005 ; 70: 61134-61145.
Concentration-QT relationships play a key role in the evaluation of proarrthythmic risk during regulatory review
Garnett CE, Beasley N., Bhattaram VA, et al. Concentration-QT relationships play a key role in the evaluation of proarrthythmic risk during regulatory review. J Clin Pharmacol. 2008 ; 48: 13-18. 3. Russell T., Riley SP, Cook JA, Lalonde RL A perspective on the use of concentration-QT modeling in drug development. J Clin Pharmacol. 2008 ; 48: 9-12.
Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates
Bloomfield D., Krishna R. Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates. J Clin Pharmacol. 2008 ; 48: 6-8.
Assessment of QTc Interval Prolongation in A Phase 1 Study Using Monte Carlo Simulation
Kimko H, Duffull S, eds. New York: Marcel Dekker;
Bonate PL Assessment of QTc interval prolongation in a phase 1 study using Monte Carlo simulation. In: Kimko H, Duffull S, eds. Simulation in Clinical Trials. New York: Marcel Dekker ; 2003 ; 353-367.
Assessment of QTc prolongation for noncardiac-related drugs from a drug development perspective
Bonate PL, Russell T. Assessment of QTc prolongation for noncardiac-related drugs from a drug development perspective. J Clin Pharmacol. 1999 ; 39: 349-358.
Pharmacokinetic-pharmacodynamic modeling in the data analysis and interpretation of drug-induced QT/QTc prolongation
Piotrovsky V. Pharmacokinetic-pharmacodynamic modeling in the data analysis and interpretation of drug-induced QT/QTc prolongation. AAPS J. 2005 ; 7: E609 - E624.
US Food and Drug Administration (FDA) Rockville, MD : FDA;
US Food and Drug Administration (FDA). Guidance for Industry: Population Pharmacokinetics. Rockville, MD: FDA ; 1999. http://www.fda.gov/cder/guidance/ 1852fnl.pdf.
Diurnal variation of ECG intervals and R or T amplitudes in healthy male subjects assessed by means of spectral and cosinor analysis
Koch HJ, Raschka C., Banzer W. Diurnal variation of ECG intervals and R or T amplitudes in healthy male subjects assessed by means of spectral and cosinor analysis. Jpn Heart J. 1999 ; 40: 45-53.
Near-thorough QT study as part of a first-in-man study
Baltimore, MD.
Malik M., Hnatkova K., Ford J., Madge D. Near-thorough QT study as part of a first-in-man study. J Clin Pharmacol. 2008 ; 46: 1146-1157. 13. Zhang J. Current E14-derived approach to design and statistical analysis of TQT studies. Presented at: ACCP Symposium: "Industry and Regulatory Experience With Thorough ECG Trials (TQT): Two Years After ICH E14" ; May 2, 2007 ; Baltimore, MD.
Application of C-QTc modeling to support regulatory and drug development decisions
Garnett CE Application of C-QTc modeling to support regulatory and drug development decisions. Presented at: ACCP 2007 QTc Frontiers Symposium ; May 2007 ; Baltimore, MD.
