Bloomfield D M
Cardiovascular Global Clinical Development, Merck and Co., Inc. Rapporteur, ICH E14 Working Group.
Clin Pharmacol Ther. 2015 May;97(5):444-6. doi: 10.1002/cpt.92. Epub 2015 Apr 3.
ICH E14 mandates that a thorough QTc study (TQT) is conducted as part of the clinical drug development program to provide an accurate and precise estimate of a drug's effect on the QTc. In the April issue of CPT, Darpo et al. report the results of a study which validated an alternative approach to evaluating the effect of a drug on QTc using exposure-response modeling in phase I which has the potential to make the TQT study obsolete.
国际协调会议（ICH）E14要求进行全面的QTc研究（TQT），作为临床药物开发计划的一部分，以准确、精确地评估药物对QTc的影响。在《临床药理学与治疗学》（CPT）四月刊中，达波等人报告了一项研究结果，该研究验证了一种在I期使用暴露-反应模型评估药物对QTc影响的替代方法，这种方法可能会使TQT研究过时。
