ICH guideline
ICH S7B: The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT…
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S7B |
|---|---|
| Title | The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was adopted under Step 4 in May 2005. This Guideline describes a non-clinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. This Guideline includes information concerning non-clinical assays and integrated risk assessments. |
| File | S7B Concept Paper |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S7B Concept Paper 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.