| 摘要: |
| 通过梳理细菌内毒素检查法建立的关键步骤,对细菌内毒素限值制定、MVD或MVC的计算、实验材料、实验过程和质量标准等涉及的评审要点进行了归纳总结,对评审过程中发现的常见问题进行了分析,以期为新兽药生产企业制定相应产品的细菌内毒素检查方法提供参考。 |
| 关键词: 细菌内毒素检查法 评审要点 常见问题 |
| DOI： |
| 投稿时间：2023-03-14修订日期：2024-01-05 |
| 基金项目:国家重点研发计划项目（2022YFD1802105） |
|
| The Key Points in the Review of the Bacterial Endotoxin Test and Analysis of the Common Problems in the Registration Data |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| By sorting out the key steps for the establishment of bacterial endotoxin test, the review points involved in the establishment of bacterial endotoxin limit, the calculation of MVD or MVC, experimental materials, experimental process and quality standards are summarized, and the common problems found in the review process are analyzed, with a view to providing a reference for new veterinary drug manufacturers to develop the bacterial endotoxin test method for corresponding products. |
| Key words: Bacterial endotoxin test Review points Common problems |
