Abstract��OBJECTIVE To discuss the strategy of strengthening ECG monitoring in phase I study and to provide references for the necessity of thorough QT/QTc study and for the subsequent development strategies. METHODS Relevant progresses in cardiac safety studies and guidelines of QT/QTc study were referred to in discussing the study strategy. RESULTS The applicable scope, protocol design and quality control of the strengthening ECG monitoring study have been preliminarily explored. CONCLUSIONS Based on the phase I clinical trials,cardiac safety of the new drugs is preliminarily evaluated and screened,without increasing drug exposure, and this study during phase I clinical trial will provide basis and reference for the further QT/QTc trial.
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XUE Wei, LI Ke-xin. Strategy Discussion of Strengthening ECG Monitoring in Phase I Clinical Trials of Investigational New Drugs. Chinese Pharmaceutical Journal, 2015, 50(13): 1153-1155.
JOHN F, DANIEL B, KATHLEENU,et al.New precompetitive paradigms: Focus oncardiac safety.Am Heart J, 2009, 157(5):825-826. DANIEL L. ICH E14:A new global regulatory guideline on clinical evaluation of cardiacsafety for new drug development programs. Chin J Clin Pharmacol Ther(�й��ٴ�ҩ��������ѧ),2006,11(1): 116-120. GUO J C, LI H Y. Cardiac safety evaluation of innovative drugs and thorough QT/QTc study . Chin Pharm J(�й�ҩѧ��־), 2012, 47(15): 1185-1188. ICH Harmonized Tripartite Guideline E14.The clinical evaluationof QT /QTc interval prolongation and proarrhythmic potential fornonantiarrhythmic drugs . http: / /www.Fda. gov /cder / guidance /8466 fnl. pdf. BORJEED, CHRISTINE G, CHARLES T B,et al. Cardiac safety research consortium: Can thethorough QT/QTc study be replaced by earlyQT assessment in routine clinicalpharmacology studies? Scientific update anda research proposal for a path forward. Am Heart J, 2014, 168(3): 262-272. DARPO B, SARAPA N, GARNETT C, et al. The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?" . Ann Noninvasive Electrocardiol, 2014, 19(1):70-81. ICH Harmonized Tripartite Guideline S7A.Safety pharmacology studies for human pharmaceuticals . http://www.ich.org/LOB/media/MEDIA504.pdf. ICH Harmonized Tripartite Guideline S7B.The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals .http: //www.ich.org/LOB/media/MEDIA2192.pdf. MIN S S, TURNER J R, NADA A, et al. Evaluation of ventricular arrhythmias in early clinical pharmacology trials and potential onsequences for later development .Am Heart J,2010,159(5): 716-729.
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