ICH-M7
| Topic | Replies | Views | Activity | |
|---|---|---|---|---|
| N-nitroso Des-ethyl Abemaciclib |
|
0 | 36 | October 12, 2026 |
| FDA Approves Reformulated Ranitidine - Nitrosamine Impurities - NDMA |
|
3 | 668 | November 27, 2025 |
| Addendum to ICH M7 on Risk Assessment and Control of N-Nitrosamine Impurities |
|
8 | 2967 | July 3, 2025 |
| 🇲🇽 Free Lhasa México Symposia: Shaping the Future of Pharma & Regulation 🇲🇽 |
|
0 | 151 | May 13, 2025 |
| Industrial Case Studies Demonstrating Applicability of ICH M7Control Options 3 and 4 for Nitrosamine Control -Pub |
|
4 | 859 | April 22, 2025 |
| ICH M7 & Nitrosamines Impurities -Updates |
|
15 | 5717 | January 20, 2025 |
| Synthesis and mutagenic risk of avanafil's potential genotoxic impurities -Pub |
|
0 | 205 | August 25, 2024 |
| Classification of potentially mutagenic impurities under the ICH M7 guideline -Event |
|
0 | 443 | July 23, 2024 |
| Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies -Pub |
|
0 | 698 | July 23, 2024 |
| Non-mutagenic, carcinogenic impurities |
|
3 | 832 | June 30, 2024 |