To establish noninferiority in QT/QTc prolongation of a test drug with respect to either a placebo or an active control, a thorough QT/QTc study is recommended by ICH (ICH E14, ICH 2005) which concerns statistical inference on the maximal time-matched drug effect. The existing statistical ...
A Simulation Study of Power in Thorough QT/QTc Studies and a Normal Approximation for Planning Purposes - Hosmane, Locke - 2005Hosmane, B. and Locke, C. (2005) A Simulation Study of Power in Thorough QT/QTc Studies and a Normal Approximation for Planning Purposes. Drug Information Journal ...
Mandal B,Kaur G,Batra YK,Mahajan S.Manifestation of Long QT syndrome with normal QTc interval under an- esthesia: a case report. Paediatric Anaesthesia . 2011MANDAL B, KAUR G, BATRA YK, MAHAJAN S. Manifes- tation of long QT syndrome with normal QTc in- terval under anesthesia: a case...
To establish noninferiority in QT/QTc prolongation of a test drug with respect to either a placebo or an active control, a thorough QT/QTc study is recommended by ICH (ICH E14, ICH 2005) which concerns statistical inference on the maximal time-matched drug effect. The existing statistical ...
QTc interval was calculated using Bazett's formula (QTc = QT interval/square root R-R interval). Student t-test and Pearson's correlation coefficient were used for statistical analysis. Results: There was no significant difference between Groups I and II in mean age, weight, height, and ...
Fridericia, Framingham, and Hodges, are also used. This study compares these four formulae using 10,303 normal ECGs recorded from four US hospitals. QT intervals were measured by the same computer program on ECGs confirmed by physicians. The distributions of QTc based on Fridericia, Framingham, ...