ICH guideline
ICH E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E14 |
|---|---|
| Title | The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH harmonised Guideline was finalised under Step 4 in May 2005. This document provides recommendations to sponsors concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarisation. This assessment should include testing the effects… |
| File | E14 Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E14 Guideline Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.