ICH guideline
ICH E14/S7B Q&A (R1): Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E14/S7B Q&A (R1) |
|---|---|
| Title | Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH E14 and ICH S7B Guidelines describe clinical and nonclinical risk assessment strategies to inform the potential risk for delayed depolarisation and proarrhythmia of a test substance and contribute to the design of clinical investigations. Emergent data over the past several years allow a more integrated… |
| File | E14/S7B Q&As(R1) Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- E14/S7B Q&As(R1) Step 4 Presentation Files published by ICH
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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.