-
1
-
-
77952506326
-
-
US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry. E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs., Accessed March 22, 2010
-
US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry. E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs., Accessed March 22, 2010. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucml29357.pdf.
-
-
-
-
2
-
-
33845978737
-
Cardiac repolarization and the safety of new drugs defined by electrocardiography
-
Morganroth J Cardiac repolarization and the safety of new drugs defined by electrocardiography. Clin Pharmacol Ther 2007, 81:108-113.
-
(2007)
Clin Pharmacol Ther
, vol.81
, pp. 108-113
-
-
Morganroth, J.1
-
3
-
-
1942536148
-
Drug-induced torsades de pointes and implications for drug development
-
for the Independent Academic Task Force
-
Fenichel RR, Malik M, Antzelevitch C, et al. Drug-induced torsades de pointes and implications for drug development. J Cardiovasc Electrophysiol 2004, 15:475-495. for the Independent Academic Task Force.
-
(2004)
J Cardiovasc Electrophysiol
, vol.15
, pp. 475-495
-
-
Fenichel, R.R.1
Malik, M.2
Antzelevitch, C.3
-
4
-
-
0035150202
-
Antipsychotic drugs: Prolonged QTc interval, torsade de pointes, and sudden death
-
Glassman AH, Bigger JT Antipsychotic drugs: Prolonged QTc interval, torsade de pointes, and sudden death. Am J Psychiatry 2001, 158:1774-1782.
-
(2001)
Am J Psychiatry
, vol.158
, pp. 1774-1782
-
-
Glassman, A.H.1
Bigger, J.T.2
-
5
-
-
0142209158
-
Drug induced QT prolongation and torsades de pointes
-
Yap YG, Camm AJ Drug induced QT prolongation and torsades de pointes. Heart 2003, 89:1363-1372.
-
(2003)
Heart
, vol.89
, pp. 1363-1372
-
-
Yap, Y.G.1
Camm, A.J.2
-
6
-
-
0024451932
-
Stereoselective disposition of flecainide in relation to the sparteine/debrisoquine metaboliser phenotype
-
Gross AS, Mikus G, Fischer C, et al. Stereoselective disposition of flecainide in relation to the sparteine/debrisoquine metaboliser phenotype. Br J Clin Pharmacol 1989, 28:555-566.
-
(1989)
Br J Clin Pharmacol
, vol.28
, pp. 555-566
-
-
Gross, A.S.1
Mikus, G.2
Fischer, C.3
-
7
-
-
77952529005
-
-
Tambocor-flecainide acetate tablet. 3M Pharmaceuticals., Accessed March 22, 2010
-
Tambocor-flecainide acetate tablet. 3M Pharmaceuticals., Accessed March 22, 2010. http://www.dailymed.nlm.nih.gov/dallymed/drugInfo.cfm?id=1423.
-
-
-
-
8
-
-
0021345989
-
Flecainide: Its proarrhythmic effect and expected changes on the surface electrocardiogram
-
Morganroth J, Horowitz LN Flecainide: Its proarrhythmic effect and expected changes on the surface electrocardiogram. Am J Cardiol 1984, 53:89B-94B.
-
(1984)
Am J Cardiol
, vol.53
-
-
Morganroth, J.1
Horowitz, L.N.2
-
9
-
-
33751220808
-
Torsade-de-pointes in a patient under flecainide treatment, an unusual case of proarrhythmicity
-
Nogales Asensio JM, Moreno Sánchez N, Doncel Vecino LJ, et al. Torsade-de-pointes in a patient under flecainide treatment, an unusual case of proarrhythmicity. Int J Cardiol 2007, 114:E65-E67.
-
(2007)
Int J Cardiol
, vol.114
-
-
Nogales Asensio, J.M.1
Moreno Sánchez, N.2
Doncel Vecino, L.J.3
-
10
-
-
0141519143
-
Flecainide induced ventricular tachycardia (torsades de pointes)
-
Thevenin J, Da Costa A, Roche F, et al. Flecainide induced ventricular tachycardia (torsades de pointes). Pacing Clin Electrophysiol 2003, 26:1907-1908.
-
(2003)
Pacing Clin Electrophysiol
, vol.26
, pp. 1907-1908
-
-
Thevenin, J.1
Da Costa, A.2
Roche, F.3
-
11
-
-
55149095948
-
Pharmacokinetic interaction of flecainide and paroxetine in relation to the CYP2D610 allele in healthy Korean subjects
-
Lim KS, Cho JY Jang IJ, et al. Pharmacokinetic interaction of flecainide and paroxetine in relation to the CYP2D610 allele in healthy Korean subjects. Br J Clin Pharmacol 2008, 66:660-666.
-
(2008)
Br J Clin Pharmacol
, vol.66
, pp. 660-666
-
-
Lim, K.S.1
Cho JY Jang, I.J.2
-
12
-
-
70350230145
-
Comparison of manual and automated measurements of the QT interval in healthy volunteers: An analysis of five thorough QT studies
-
Fosser C, Duczynski G, Agin M, et al. Comparison of manual and automated measurements of the QT interval in healthy volunteers: An analysis of five thorough QT studies. Clin Pharmacol Ther 2009, 86:503-506.
-
(2009)
Clin Pharmacol Ther
, vol.86
, pp. 503-506
-
-
Fosser, C.1
Duczynski, G.2
Agin, M.3
-
13
-
-
11144273910
-
Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation
-
Malik M, Hnatkova K, Batchvarov V, et al. Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation. Pacing Clin Electrophysiol 2004, 27:1659-1669.
-
(2004)
Pacing Clin Electrophysiol
, vol.27
, pp. 1659-1669
-
-
Malik, M.1
Hnatkova, K.2
Batchvarov, V.3
-
14
-
-
70349306367
-
Comparison of semiautomated and fully automated methods for QT measurement during a thorough QT/QTc study: Variability and sample size considerations
-
Tyl B, Kabbaj M, Fassi B, et al. Comparison of semiautomated and fully automated methods for QT measurement during a thorough QT/QTc study: Variability and sample size considerations. J Clin Pharmacol 2009, 49:905-915.
-
(2009)
J Clin Pharmacol
, vol.49
, pp. 905-915
-
-
Tyl, B.1
Kabbaj, M.2
Fassi, B.3
-
15
-
-
40549135640
-
Effect of single doses of maraviroc on the QT/QTc interval in healthy subjects
-
Davis JD, Hackman F, Layton G, et al. Effect of single doses of maraviroc on the QT/QTc interval in healthy subjects. Br J Clin Pharmacol 2008, 65(Suppl 1):68-75.
-
(2008)
Br J Clin Pharmacol
, vol.65
, Issue.SUPPL. 1
, pp. 68-75
-
-
Davis, J.D.1
Hackman, F.2
Layton, G.3
-
16
-
-
0027454955
-
Pharmacodynamic variability of flecainide assessed by QRS changes
-
Padrini R, Piovan D, Busa M, et al. Pharmacodynamic variability of flecainide assessed by QRS changes. Clin Pharmacol Ther 1993, 53:59-64.
-
(1993)
Clin Pharmacol Ther
, vol.53
, pp. 59-64
-
-
Padrini, R.1
Piovan, D.2
Busa, M.3
-
17
-
-
0028236315
-
Variable disposition kinetics and electrocardiographic effects of flecainide during repeated dosing in humans: Contribution of genetic factors, dose-dependent clearance, and interaction with amiodarone
-
Funck-Brentano C, Becquemont L, Kroemer HK, et al. Variable disposition kinetics and electrocardiographic effects of flecainide during repeated dosing in humans: Contribution of genetic factors, dose-dependent clearance, and interaction with amiodarone. Clin Pharmacol Ther 1994, 55:256-269.
-
(1994)
Clin Pharmacol Ther
, vol.55
, pp. 256-269
-
-
Funck-Brentano, C.1
Becquemont, L.2
Kroemer, H.K.3
-
18
-
-
15844417196
-
Torsade de pointes in patients on chronic amiodarone treatment: Contributing factors and drug interactions
-
Antonelli D, Atar S, Freedberg NA, Rosenfeld T Torsade de pointes in patients on chronic amiodarone treatment: Contributing factors and drug interactions. Isr Med Assoc J 2005, 7:163-165.
-
(2005)
Isr Med Assoc J
, vol.7
, pp. 163-165
-
-
Antonelli, D.1
Atar, S.2
Freedberg, N.A.3
Rosenfeld, T.4
-
19
-
-
54049134890
-
Relationship among amiodarone, new class III antiarrhythmics, miscellaneous agents and acquired long QT syndrome
-
Riera AR, Uchida AH, Ferreira C, et al. Relationship among amiodarone, new class III antiarrhythmics, miscellaneous agents and acquired long QT syndrome. Cardiol J 2008, 15:209-219.
-
(2008)
Cardiol J
, vol.15
, pp. 209-219
-
-
Riera, A.R.1
Uchida, A.H.2
Ferreira, C.3
-
20
-
-
18844426008
-
In vitro-in vivo extrapolation of CYP2D6 inactivation by paroxetine: Prediction of nonstationary pharmacokinetics and drug interaction magnitude
-
Venkatakrishnan K, Obach RS In vitro-in vivo extrapolation of CYP2D6 inactivation by paroxetine: Prediction of nonstationary pharmacokinetics and drug interaction magnitude. Drug Metab Dispos 2005, 33:845-852.
-
(2005)
Drug Metab Dispos
, vol.33
, pp. 845-852
-
-
Venkatakrishnan, K.1
Obach, R.S.2
-
21
-
-
58149231177
-
Detection of clinically significant QTc prolongation in phase studies in healthy participants: Comparison of 2 semiautomated QT measurement methods
-
Sarapa N, Francom SF, Azzam SM, et al. Detection of clinically significant QTc prolongation in phase studies in healthy participants: Comparison of 2 semiautomated QT measurement methods. J Clin Pharmacol 2009, 49:103-108.
-
(2009)
J Clin Pharmacol
, vol.49
, pp. 103-108
-
-
Sarapa, N.1
Francom, S.F.2
Azzam, S.M.3
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