ICH guideline
ICH S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S1C(R2) |
|---|---|
| Title | Dose Selection for Carcinogenicity Studies of Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This document addresses the criteria for the selection of the high dose to be used in carcinogenicity studies on new therapeutic agents to harmonise current practices and improve the design of studies. The Addendum on "Addition of a Limit Dose and Related Notes", finalised in July 1997, has been incorporated into the… |
| File | S1C(R2) Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S1C(R2) 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.