ICH E14 :a new global regulatory guideline on clinical evaluation of car- diac safety for new drug development programs

Abstract

Abstract: In May 2005, resolutions on how cardia safety of a new drug should be monitored during its clini- cal studies were concluded with publication of an intensive International Conference on Harmonization ( ICH) pro- cess, leading to the document :ICH Harmonized Tripatite Guideline:The clinical evaluation of QT QTc interval prolongation and proarrhythmic potential for non -antiaa- hythmic drugs ( ICH E 14) .The review presented this guidance with commentary on areas requiring more clarifi- cations that will be useful in developing China' s strategies of cardiac safety programs of new drugs to ensure compli- ance with good clinical practice .

Key words: ICH E14 , heart , security , new drug exploiture , international

CLC Number:

R969

Daniel Liu. ICH E14 :a new global regulatory guideline on clinical evaluation of car- diac safety for new drug development programs[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(1): 116-120.

References 12

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3	ICH Harmonized Tripartite Guideline:The non -clinical evalu-ation of the potential for delayed ventricular polarization ( QT in-terval prolongation) by human pharmaceuticals[ S] .S7B, Step4, 12 May 2005, Page 2, Section 2.1
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