Inspiration on China's national biological reference standards from WHO's guidelines and practices on stability of biological reference standards
10.13200/j.cnki.cjb.004496
- VernacularTitle:WHO生物标准物质稳定性研究指南文件和研究实例对我国国家生物标准物质的启示
- Author:
WANG Yiping
- Publication Type:Journal Article
- Keywords:
Reference material;
Real-time stability;
Accelerated stability
- From:
Chinese Journal of Biologicals
2025;38(06):764-768
- CountryChina
- Language:Chinese
-
Abstract:
Stability represents a critical quality attribute of reference materials. To ensure the stability of biological reference standards, World Health Organization(WHO) has continuously refined and elaborated the stability requirements in guidelines for both international(primary) and national(secondary) biological reference materials, aiming to enhance the scientificity and operability of stability studies and monitoring. Based on a summarization of the WHO guidelines on stability studies for biological reference standards and case studies of international reference standards development documented in the literature, this paper proposes considerations and recommendations for improving stability studies and stability monitoring of national biological reference standards in China.
