ICH guideline
ICH S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity…
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S3A |
|---|---|
| Title | Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in October 1994. This document gives guidance on developing test strategies in toxicokinetics and highlights the need to integrate pharmacokinetics into toxicity testing, in order to aid in the interpretation of the toxicology findings and promote rational study… |
| File | S3A Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S3A Guideline 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.