Regulatory Focus™ > News Articles > ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs

ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs

Posted 11 May 2012 | By Alexander Gaffney, RAC 

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released an updated version of its Efficacy (E) 14 Guideline, providing four new pieces of insight on the clinical evaluation of non-antiarrhythmic drugs.

ICH's Q&A document for E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs was originally released under Step 4 of the ICH process on 4 June 2008.

The guideline describes how to evaluate the QT/QTC intervals and proarrhythmic potential of patients being given non-antiarrhythmic drugs, which can be used to sudden cardiac deaths.

On 5 April 2012, ICH's Steering Committee approved four additional revisions to the document, which covers the use of different sexes in clinical trials, the use of new technologies in clinical trials, approaches to evaluating QT intervals in late-stage development, and correcting submissions using "Fridericia's and Bazett's correction."


Read more:

E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

ICH - Efficacy Guidelines


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