| 摘要: |
| 介绍了兽药使用期间稳定性试验的概念，阐述了对使用前需要重新配制和多剂量包装的制剂进行使用期间稳定性试验的重要意义，结合国外有关指导文件对药物使用期间稳定性要求及使用期间稳定性试验研究的技术要求进行了探讨，为使用期间稳定性试验的开展提供参考。 |
| 关键词: 兽药 使用期间稳定性试验 多剂量包装产品 使用期限 |
| DOI： |
| 投稿时间：2012-10-11修订日期：2012-11-01 |
| 基金项目: |
|
| Reflection and Suggestion on In-use Stability Testing of Veterinary Drug Products |
|
| (china Institute of veterinary Drug Control) |
| Abstract: |
| The concept of in-use stability testing is introduced in this paper. The importance of in-use stability testing for multidose drug products and /or products which needs constitution or dilution before use is emphasized. Based on system in analysis for various key elements in requirements of in-use stability testing of EMEA and ICH guidelines, the main technique requirements of veterinary drug products are put forward in order to provide a reference for carrying out this work. |
| Key words: in-use stability testing multidose drug products in-use duration |
