# M10 BIOANALYTICAL METHOD VALIDATION - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/m10-bioanalytical-method-validation/0bcad818-8b44-4227-b811-ea24e68f81cd

> FDA guidance document: M10 BIOANALYTICAL METHOD VALIDATION. Issue date: June 26, 2019. Get complete insights and analysis.

---

## Details

- Title: M10 BIOANALYTICAL METHOD VALIDATION
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-06-26
- Comment Close Date: 2019-08-26
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-1469">FDA-2019-D-1469</a>

## Related Documents

- [M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality](https://www.globalkeysolutions.net/guidances/guidance-document/m4qr2-the-common-technical-document-for-the-registration-of-pharmaceuticals-for-human-use-quality/99d9c6a0-e416-4075-875d-80fbbf761ac7)
- [Q3E Guideline for Extractables and Leachables](https://www.globalkeysolutions.net/guidances/guidance-document/q3e-guideline-for-extractables-and-leachables/4b0a399e-ea86-4269-bcb2-e0cf8c88b5bd)
- [E19 OPTIMISATION OF SAFETY DATA COLLECTION](https://www.globalkeysolutions.net/guidances/guidance-document/e19-optimisation-of-safety-data-collection/e2f8a0da-582a-4c4a-946d-b9039d8729bb)
