生物制品稳定性研究考虑因素及常见缺陷分析
Factors Considered and Common Defects Analysis of Biological Products Stability Test
刘荣 1冯巧巧 1董方 2钱璟 3沈振铎 4李武超 2梁锦锋3
作者信息
- 1. 山东省食品药品审评查验中心,济南 250014
- 2. 国家药品监督管理局食品药品审核查验中心,北京 100076
- 3. 浙江省药品化妆品审评中心,杭州 310012
- 4. 山东博安生物技术股份有限公司,山东烟台 264670
- 折叠
摘要
生物制品与其他药品具有明显的区别,其本身具有复杂多变的特点,对光线、温度等影响因素高度敏感,在满足普通药品稳定性有关要求的前提下,应更多地关注影响其质量的因素.生物制品在开展稳定性研究时应关注影响其质量和有效期等的因素,结合其产品特点、结构特性、质量标准制定等情况,制定适合其产品稳定性考察的方案并有效执行,控制风险.本文通过对生物制品稳定性研究的有关因素及常见缺陷分析,旨在为稳定性研究提供参考和借鉴.
Abstract
Study on the stability of biological products are different from other drugs due to their complex and changeable characteristics and highly sensitive to light,temperature,and other influencing factors.On the premise of meeting the stability requirements of common drugs,more attention should be paid to the factors affecting its quality.The stability research of biological products should pay attention to the factors affecting their quality and expiration date.It is advisable to develop a plan suitable for its product stability inspection and implement it effectively to control risks based on its product characteristics,structural characteristics,and quality standards.This article analyzes factors and common defects in stability research of biological products,providing references and guidance for stability research.
关键词
生物制品/稳定性研究/质量标准/影响因素/检查缺陷Key words
biological product/stability test/quality standard/influencing factor/detect defects引用本文复制引用
出版年
2024
NETL
NSTL
万方数据