ICH guideline
ICH M13C EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
ICH guideline · Multidisciplinary Guidelines
Key facts
| ICH code | M13C EWG |
|---|---|
| Title | Bioequivalence for Immediate-Release Solid Oral Dosage Forms |
| Guideline series | Multidisciplinary Guidelines |
| ICH summary (excerpt) | Part of the foreseen ICH M13 Guideline series (M13A-C), the ICH M13C Guideline is intended to provide recommendations on data analysis and BE assessment for 1) highly variable drugs, 2) drugs with narrow therapeutic index, and 3) complex BE study design and data analysis considerations, e.g., adaptive BE study design… |
| File | M13C Concept Paper Supplement |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M13C Concept Paper Supplement 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.