ICH E14: a new global regulatory guideline on clinical evaluation of cardiac safety for new drug development programs
- VernacularTitle:ICH E14:一项新的评价新药研发中药物临床心脏安全性的国际药政法规
- Author:
Liu DANIEL
;
- Publication Type:Journal Article
- Keywords:
ICH E14;
heart;
security;
new drug exploiture;
international
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2000;0(01):-
- CountryChina
- Language:Chinese
-
Abstract:
In May 2005,resolutions on how cardia safety of a new drug should be monitored during its clinical studies were concluded with publication of an intensive International Conference on Harmonization(ICH) process,leading to the document: ICH Harmonized Tripatite Guideline: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiaahythmic drugs(ICH E 14).The review presented this guidance with commentary on areas requiring more clarifications that will be useful in developing China's strategies of cardiac safety programs of new drugs to ensure compliance with good clinical practice.
