ICH guideline
ICH M13B EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
ICH guideline · Multidisciplinary Guidelines · Step 4
Key facts
| ICH code | M13B EWG |
|---|---|
| Title | Bioequivalence for Immediate-Release Solid Oral Dosage Forms |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 4 |
| ICH summary (excerpt) | Part of the foreseen ICH M13 Guideline series (M13A-C), the ICH M13B Guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths… |
| File | M13B Q&As |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M13B Q&As 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.