ICH guideline
ICH M13A Q&As: Question and Answers: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M13A Q&As |
|---|---|
| Title | Question and Answers: Bioequivalence for Immediate-Release Solid Oral Dosage Forms |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | ICH M13A Questions and Answers (Q&As) have been developed to provide clarity on concepts related to the evaluation of bioequivalence for immediate-release solid oral dosage forms as covered in the Guideline. This Q&A document is intended to offer additional clarification and improve harmonization.The scope and… |
| File | M13A Q&As |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M13A 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.