Statistical Issues Including Design and Sample Size Calculation in Thorough QT/QTc Studies ICH E14 Guidance. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Nonantiarrhythmic Drugs . International Conference on... JZ&SG Machado - 《Journal of Biopharmaceutical Stat...
Some pharmaceutical companies have started to use "hybrid TQT" study to meet ICH E14 regulatory requir... DP Huang,J Chen,Q Dang,... - 《Journal of Biopharmaceutical Statistics》 被引量: 0发表: 2018年 Statistical Issues Including Design and Sample Size Calculation in Thorough QT/QTc Studies...
An analysis of QTc data collected in four thorough QT studies conducted at Eli Lilly and Company was performed to estimate the variability of the QTc interval and to calculate the variance components related to time-to-time, day-to-day variability, etc. The results were used to develop a sam...
The cost for conducting a thorough QT/QTc study is substantial and an unsuccessful outcome of the study can be detrimental to the safety profile of the drug, so sample size calculations play a very important role in ensuring adequate power for a thorough QT study. Current literature offers some...
Conclusions As calculation of QTc dispersion is affected by sinus arrhythmia, which is common in childhood, we suggest that QT dispersion should not be corrected for heart rate in children.H Ercan TutarAnkara University Faculty of MedicineDepartment of Pediatric CardiologyB ?cal...
Consequently, these data should incite prompt modification of the QTc calculation formula provided by computed ECG machines. Furthermore, uniform criteria and guidelines for selection of QTc formula need to be developed. Formula-specific QTc thresholds also need to be specified. Given that the Bazett...
which makes it one of the most important reasons for sudden cardiac death in hospital. In the calculation of QT/QTc intervals, to evaluate ventricular repolarization as accurately as possible in different methods within the recommended range of critical value of QT/QTc interval prolongation time can...
To evaluate the consequences of using correction formulae such as equation (1), which is the most used in the literature19, we plotted the same data as shown in Fig. 4A,B, but using QTc instead of the raw QT. As shown in Fig. 4C,D, the mean variations in QTc became ...
目前最常用的计算QTc的公式为Bazett提出的方程,即 QTc = QT / RR 1/2 。 Bazett’s方程有一定的适用范围,即当心率为50～90次/分时,经该方程矫正得到的QTc较为准确。而当心率偏快时,经Bazett’s方程矫正的QTc值常偏大。而当患者的心率较慢时,经Bazett’s方程矫...
In response to the questions regarding measurements of QTc, it is our practice to manually measure the QT interval in cases where we are concerned, and we typically use the Bazett formula for calculation of the QTc. It is important to manually confirm QT intervals in the presence of abnormal...