Introduction of ICH E14 Clinical Evaluation of QT Prolongation Caused by Non-Antiarrhythmic Drug: Q&As (R3)
10.7501/j.issn.1674-6376.2017.10.003
- VernacularTitle:ICH E14《非抗心律失常药所致QT延长临床评价:问答第3次修订版》介绍
- Author:
lai Hui XIAO
1
Author Information
1. 国家食品药品监督管理总局药品审评中心
- Keywords:
ICH;
non-antiarrhythmic drug;
QT interval prolongation;
clinical evaluation;
guidance
- From:
Drug Evaluation Research
2017;40(10):1378-1385
- CountryChina
- Language:Chinese
-
Abstract:
To detect and determine the QT interval prolongation caused by non antiarrhythmic drugs,ICH released the E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs and released E14's questions and answers (ICH E14 Q&As) in 2008 which explained some specific questions.Subsequently,This Q&As were revised third times and in June 2017 forwarded by FDA.The number of questions and answers in the revised edition doubled compared with the original.This article introduces the details of this revised edition,and hopes to be helpful to the research and supervision in China.
