ICH guideline
ICH Q4B Annex 7(R2): Dissolution Test General Chapter
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q4B Annex 7(R2) |
|---|---|
| Title | Dissolution Test General Chapter |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Annex was finalised under Step 4 in October 2009. This annex is the result of the Q4B process for Dissolution Test General Chapter. This annex was revised (R1) on 27 September 2010 to include the Interchangeability Statement from Health Canada, Canada. On 11 November 2010 the ICH Steering Committee… |
| File | Q4B Frequently Asked Questions (FAQs) |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q4B Frequently Asked Questions (FAQs) Files published by ICH
- None 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.