ICH guideline
ICH S11: Nonclinical Safety Testing in Support of Development of Paediatric Medicines
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S11 |
|---|---|
| Title | Nonclinical Safety Testing in Support of Development of Paediatric Medicines |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The S11 Guideline provides direction on the nonclinical safety studies important to support a paediatric development programme. It recommends standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and also provides… |
| File | S11 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S11 Step 4 Presentation 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.