ICH guideline
ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q1D |
|---|---|
| Title | Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in February 2002. This document is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability Guideline. |
| File | Q1D Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- Q1D Guideline Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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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.