ICH guideline
ICH M10: Bioanalytical Method Validation and Study Sample Analysis
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M10 |
|---|---|
| Title | Bioanalytical Method Validation and Study Sample Analysis |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This Guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples. Adherence to the principles presented in this Guideline will ensure the quality and consistency of the bioanalytical… |
| File | M10 Training Materials |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M10 Training Materials Files published by ICH
- 1–9 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.