生物制品稳定性研究相关问题的考虑

摘要

稳定性研究是贯穿于整个药物研究阶段和支持药物上市及上市后研究的重要试验依据,是产品贮藏条件、有效期的确定和生产工艺、产品制剂处方、包装材料选择的合理性及产品质量标准制定的研究基础.因此,如何设计、开展稳定性研究是研发需要重视的内容.本文拟以生物制品为例,提出有关稳定性研究的探讨意见.%Stability test always goes through the whole process of drug research and development, also it is the important data to support drug on marketing and after marketing. Data from the stability test should lay the foundation for determination of drug storage condition, expiry date, production process, formulation, packaging and quality standard. Therefore, how to design and carry out the stability test is the focus. Here reviewer's comments regarding to stability test of biological products was presented.