# M15 General Principles for Model-Informed Drug Development - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/m15-general-principles-for-model-informed-drug-development/0c262249-637c-4377-ac7f-9fc2fa0ab688

> FDA guidance document: M15 General Principles for Model-Informed Drug Development. Issue date: December 30, 2024. Get complete insights and analysis.

---

## Details

- Title: M15 General Principles for Model-Informed Drug Development
- 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: 2024-12-30
- Comment Close Date: 2025-02-28
- Last Changed: 2025-01-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-5580">FDA-2024-D-5580</a>

## Related Documents

- [Q3E Guideline for Extractables and Leachables](https://www.globalkeysolutions.net/guidances/guidance-document/q3e-guideline-for-extractables-and-leachables/4b0a399e-ea86-4269-bcb2-e0cf8c88b5bd)
- [E6(R3) Good Clinical Practice: Annex 2](https://www.globalkeysolutions.net/guidances/guidance-document/e6r3-good-clinical-practice-annex-2/8cba2156-b613-4d5b-9a03-bb5b0bc681c1)
- [Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/q1-stability-testing-of-drug-substances-and-drug-products-draft-guidance-for-industry/f97d5bb6-a78c-45d5-be86-41bb6e6c13b2)
