ICH guideline
ICH M13A EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M13A EWG |
|---|---|
| Title | Bioequivalence for Immediate-Release Solid Oral Dosage Forms |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in November 2019.Part of the foreseen ICH M13 Guideline series (M13A-C), the ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR)… |
| File | M13A Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M13A Step 4 Presentation 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.