ICH guideline
ICH S1B(R1): Testing for Carcinogenicity of Pharmaceuticals
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S1B(R1) |
|---|---|
| Title | Testing for Carcinogenicity of Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | As of August 2022, the ICH S1B(R1) Guideline integrates a new Addendum with the original S1B Guideline which was finalised under Step 4 in July 1997. This Addendum expands the evaluation process for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the… |
| File | S1B(R1) Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S1B(R1) 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.