-
1
-
-
27244456179
-
ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs: Guidance to industry
-
ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs: guidance to industry. Fed Regist. 2005 ; 70: 61134-61135.
-
(2005)
Fed Regist
, vol.70
, pp. 61134-61135
-
-
-
2
-
-
39449091890
-
Use of ANOVA to estimate inter- and intra-reader variability for a group of readers in thorough QT/QTc studies
-
Natekar M., Mahajan V., Satra A., O'Kelly M., Karnad DR Use of ANOVA to estimate inter- and intra-reader variability for a group of readers in thorough QT/QTc studies. Clin Pharmacol Ther. 2008 ; 83: 489-491.
-
(2008)
Clin Pharmacol Ther
, vol.83
, pp. 489-491
-
-
Natekar, M.1
Mahajan, V.2
Satra, A.3
O'Kelly, M.4
Karnad, D.R.5
-
3
-
-
7544230176
-
Annotated ECG waveform data at FDA
-
Stockbridge N., Brown BD Annotated ECG waveform data at FDA. J Electrocardiol. 2004 ; 37 (suppl): 63-64.
-
(2004)
J Electrocardiol
, vol.37
, pp. 63-64
-
-
Stockbridge, N.1
Brown, B.D.2
-
4
-
-
21344434324
-
Detection of drug-induced proarrhythmia: Balancing preclinical and clinical studies
-
Malik M. Detection of drug-induced proarrhythmia: balancing preclinical and clinical studies. Heart Rhythm. 2005 ; 2: 773-776.
-
(2005)
Heart Rhythm
, vol.2
, pp. 773-776
-
-
Malik, M.1
-
5
-
-
0029891439
-
Validation testing of the SEER real-time digital Holter monitor
-
London MJ Validation testing of the SEER real-time digital Holter monitor. J Cardiothorac Vasc Anesth. 1996 ; 10: 497-501.
-
(1996)
J Cardiothorac Vasc Anesth
, vol.10
, pp. 497-501
-
-
London, M.J.1
-
7
-
-
0032031794
-
Developments in ECG acquisition, preprocessing, parameter measurement, and recording
-
Daskalov IK, Dotsinsky IA, Christov II Developments in ECG acquisition, preprocessing, parameter measurement, and recording. IEEE Eng Med Biol. 1998 ; 17: 50-58.
-
(1998)
IEEE Eng Med Biol
, vol.17
, pp. 50-58
-
-
Daskalov, I.K.1
Dotsinsky, I.A.2
Christov, I.I.3
-
8
-
-
0017695924
-
Electrocardiogram baseline noise estimation and removal using cubic splines and state-space computation techniques
-
Meyer CR, Keiser HN Electrocardiogram baseline noise estimation and removal using cubic splines and state-space computation techniques. Comput Biomed Res. 1977 ; 10: 459-470.
-
(1977)
Comput Biomed Res
, vol.10
, pp. 459-470
-
-
Meyer, C.R.1
Keiser, H.N.2
-
9
-
-
0036181222
-
Relation between QT and RR intervals is highly individual among healthy subjects: Implications for heart rate correction of the QT interval
-
Malik M., Färbom P., Batchvarov V., Hnatkova K., Camm AJ 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.
-
(2002)
Heart
, vol.87
, pp. 220-228
-
-
Malik, M.1
Färbom, P.2
Batchvarov, V.3
Hnatkova, K.4
Camm, A.J.5
-
10
-
-
0036086224
-
QT-RR relationship in healthy subjects exhibits substantial inter-subject variability and high intra-subject stability
-
Batchvarov VN, Ghuran A., Smetana P., et al. QT-RR relationship in healthy subjects exhibits substantial inter-subject variability and high intra-subject stability. Am J Physiol Heart Circ Physiol. 2002 ; 282: H2356 - H2363.
-
(2002)
Am J Physiol Heart Circ Physiol
, vol.282
-
-
Batchvarov, V.N.1
Ghuran, A.2
Smetana, P.3
-
11
-
-
37349079996
-
Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review
-
Garnett CE, Beasley N., Bhattaram VA, et al. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol. 2008 ; 48: 13-18.
-
(2008)
J Clin Pharmacol
, vol.48
, pp. 13-18
-
-
Garnett, C.E.1
Beasley, N.2
Bhattaram, V.A.3
-
12
-
-
84980098899
-
Die Systolendauer im Elekrokardiogramm bei normalen Menschen und bei Herzkranken
-
Fridericia LS Die Systolendauer im Elekrokardiogramm bei normalen Menschen und bei Herzkranken. Acta Med Scand. 1920 ; 53: 469-486.
-
(1920)
Acta Med Scand
, vol.53
, pp. 469-486
-
-
Fridericia, L.S.1
-
13
-
-
0036185306
-
The impression in heart rate correction may lead to artificial observations of drug induced QT interval changes
-
Malik M. The impression in heart rate correction may lead to artificial observations of drug induced QT interval changes. Pacing Clin Electrophysiol. 2002 ; 25: 209-216.
-
(2002)
Pacing Clin Electrophysiol
, vol.25
, pp. 209-216
-
-
Malik, M.1
-
14
-
-
54249107164
-
Thorough QT/QTc study in patients with advanced Parkinson's disease-cardiac safety of rotigotine
-
Malik M., Andreas J-O., Hnatkova K., et al. Thorough QT/QTc study in patients with advanced Parkinson's disease-cardiac safety of rotigotine. Clin Pharmacol Ther. In press.
-
Clin Pharmacol Ther
-
-
Malik, M.1
Andreas, J.-O.2
Hnatkova, K.3
-
15
-
-
37549043173
-
Ritonavir 100 mg does not cause QTc prolongation in healthy subjects: A possible role as CYP3A inhibitor in thorough QTc studies
-
Sarapa N., Nickens DJ, Raber SR, Reynolds RR, Amantea MA Ritonavir 100 mg does not cause QTc prolongation in healthy subjects: a possible role as CYP3A inhibitor in thorough QTc studies. Clin Pharmacol Ther. 2008 ; 83: 153-159.
-
(2008)
Clin Pharmacol Ther
, vol.83
, pp. 153-159
-
-
Sarapa, N.1
Nickens, D.J.2
Raber, S.R.3
Reynolds, R.R.4
Ma, A.5
-
16
-
-
37549017626
-
Randomized, double-blind, crossover study to investigate the effect of rivaroxaban on QT-interval prolongation
-
Kubitza D., Mueck W., Becka M. Randomized, double-blind, crossover study to investigate the effect of rivaroxaban on QT-interval prolongation. Drug Saf. 2008 ; 31: 67-77.
-
(2008)
Drug Saf
, vol.31
, pp. 67-77
-
-
Kubitza, D.1
Mueck, W.2
Becka, M.3
-
17
-
-
33847632522
-
Thorough QT study with recommended and supratherapeutic doses of tolterodine
-
Malhotra BK, Glue P., Sweeney K., Anziano R., Mancuso J., Wicker P. Thorough QT study with recommended and supratherapeutic doses of tolterodine. Clin Pharmacol Ther. 2007 ; 81: 377-385.
-
(2007)
Clin Pharmacol Ther
, vol.81
, pp. 377-385
-
-
Malhotra, B.K.1
Glue, P.2
Sweeney, K.3
Anziano, R.4
Mancuso, J.5
Wicker, P.6
-
18
-
-
35248869253
-
Levocetirizine does not prolong the QT/QTc interval in healthy subjects: Results from a thorough QT study
-
Hulhoven R., Rosillon D., Letiexhe M., Meeus MA, Daoust A., Stockis A. Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study. Eur J Clin Pharmacol. 2007 ; 63: 1011-1017.
-
(2007)
Eur J Clin Pharmacol
, vol.63
, pp. 1011-1017
-
-
Hulhoven, R.1
Rosillon, D.2
Letiexhe, M.3
Ma, M.4
Daoust, A.5
Stockis, A.6
-
19
-
-
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., Gang Y., Smetana P., Camm AJ 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
Gang, Y.4
Smetana, P.5
Camm, A.J.6
-
20
-
-
45849094068
-
Statistical issues including design and sample size calculation in thorough QT/QTc studies
-
Zhang J., Machado SG Statistical issues including design and sample size calculation in thorough QT/QTc studies. J Biopharm Stat. 2008 ; 18: 451-467.
-
(2008)
J Biopharm Stat
, vol.18
, pp. 451-467
-
-
Zhang, J.1
MacHado, S.G.2
-
21
-
-
0029928495
-
Heart rate variability-standards of measurement, physiological interpretation, and clinical use
-
Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology.
-
Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Heart rate variability-standards of measurement, physiological interpretation, and clinical use. Circulation. 1996 ; 93: 1043-1065.
-
(1996)
Circulation
, vol.93
, pp. 1043-1065
-
-
-
22
-
-
0343416365
-
Heart rate variability: Origins, methods, and interpretative caveats
-
Berntson GG, Bigger JT Jr, Eckberg DL, et al. Heart rate variability: origins, methods, and interpretative caveats. Psychophysiology. 1997 ; 34: 623-648.
-
(1997)
Psychophysiology
, vol.34
, pp. 623-648
-
-
Berntson, G.G.1
Bigger Jr., J.T.2
Eckberg, D.L.3
-
23
-
-
2342604494
-
Comparing methods of measurement for detecting drug-induced changes in the QT interval: Implications for thoroughly conducted ECG studies
-
Azie NE, Adams G., Darpo B., et al. Comparing methods of measurement for detecting drug-induced changes in the QT interval: implications for thoroughly conducted ECG studies. Ann Noninvasive Electrocardiol. 2004 ; 9: 166-174.
-
(2004)
Ann Noninvasive Electrocardiol
, vol.9
, pp. 166-174
-
-
Azie, N.E.1
Adams, G.2
Darpo, B.3
-
24
-
-
33745228747
-
Man versus machine: Is there an optimal method for QT measurements in thorough QT studies
-
Darpo B., Agin M., Kazierad DJ, et al. Man versus machine: is there an optimal method for QT measurements in thorough QT studies ? J Clin Pharmacol. 2006 ; 46: 598-612.
-
(2006)
J Clin Pharmacol
, vol.46
, pp. 598-612
-
-
Darpo, B.1
Agin, M.2
Kazierad, D.J.3
-
25
-
-
51849131559
-
Accurately measured and heart-rate corrected QTc intervals do not show any daytime variability [abstract]
-
Malik M., Hnatkova K., Smetana P., Schmidt A. Accurately measured and heart-rate corrected QTc intervals do not show any daytime variability [abstract]. Eur Heart J. 2007 ; 28: 624.
-
(2007)
Eur Heart J
, vol.28
, pp. 624
-
-
Malik, M.1
Hnatkova, K.2
Smetana, P.3
Schmidt, A.4
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