ICH guideline
ICH S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S3B |
|---|---|
| Title | Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution 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 circumstances when repeated dose tissue distribution studies should be considered (e.g., when appropriate data cannot be derived from other sources). It also gives recommendations on the conduct of such studies. |
| File | S3B Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S3B 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.