ICH guideline
ICH S8: Immunotoxicity Studies for Human Pharmaceuticals
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S8 |
|---|---|
| Title | Immunotoxicity Studies for Human Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was adopted under Step 4 in September 2005. This Guideline provides recommendations on nonclinical testing approaches to identify compounds which have the potential to be immunotoxic, and guidance on a weight-of-evidence decision making approach for immunotoxicity testing It applies to new… |
| File | S8 Concept Paper |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S8 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.