ICH guideline
ICH M10 Q&As: Questions and Answers: Bioanalytical Method Validation and Study Sample Analysis
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M10 Q&As |
|---|---|
| Title | Questions and Answers: Bioanalytical Method Validation and Study Sample Analysis |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | ICH M10 Q&As have been devised to provide clarity around some of the bioanalytical issues covered in the ICH M10 Guideline. The ICH M10 Q&As are intended to provide additional clarification and to promote convergence and improve harmonisation of the bioanalytical method validation and study sample analysis. The scope… |
| File | M10 Q&As |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M10 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.