ICH guideline
ICH E4: Dose-Response Information to Support Drug Registration
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E4 |
|---|---|
| Title | Dose-Response Information to Support Drug Registration |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in March 1994. This document gives recommendations on the design and conduct of studies to assess the relationships among dose, drug-concentration in blood, and clinical response throughout the clinical development of a new drug. |
| File | E4 Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- E4 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.