摘要
为了发现并判断非抗心律失常药所致的QT间期延长,人用药品技术要求协调国际会议(ICH)发布了E14《非抗心律失常药致QT/QTc间期延长及潜在致心律失常作用的临床评价指导原则》。2008年ICH发布了该指导原则的问答(E14Q&As),对一些具体问题做了说明,随后又对问答做了第3次修订,问答数较原版增加了1倍。美国食品药品管理局(FDA)于2017年6月对第3次修订版予以转发。介绍该修订版的详细内容,希望对我国非抗心律失常药临床评价相关方面的研究和监管工作有益。
To detect and determine the QT interval prolongation caused by non antiarrhythmic drugs, ICH released the E14 Clinical Evaluation of QT/QTc lnterval 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.
出处
《药物评价研究》
CAS
2017年第10期1378-1385,共8页
Drug Evaluation Research
