ICH guideline
ICH S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S4 |
|---|---|
| Title | Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised ICH Guideline was finalised under Step 4 in September 1998. This guidance has been prepared for the development of medicinal products with the exception of those already covered by the ICH Guideline on Safety Studies for Biotechnological Products, e.g., Monoclonal antibodies, recombinant DNA… |
| File | S4 Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S4 Guideline Files published by ICH
- None 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.