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。
The concept of in -use stability testing is introduced in this paper. The importance testing for muhidose drug products and/or products which needs constitution or dilution before of in - use stability 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.
出处
《中国兽药杂志》
2013年第2期47-50,共4页
Chinese Journal of Veterinary Drug
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
veterinary drug products
in -use stability testing
muhidose drug products
in -use duration
