ICH guideline
ICH Q1E: Evaluation of Stability Data
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q1E |
|---|---|
| Title | Evaluation of Stability Data |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in February 2003. This document extends the main stability Guideline by explaining possible situations where extrapolation of retest periods or shelf-lives beyond the real-time data may be appropriate. Furthermore, it provides examples of statistical approaches to… |
| File | Q1E Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q1E 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.