指导原则解读系列专题(二十二) 化学药物稳定性研究的设计和评价

Concerns about the design and evaluation in drug stability tests

稳定性研究在新药和仿制药的研发中占有重要位置。科学的试验设计是稳定性合理评价的基础。文中结合实践中的经验对《化学药物稳定性研究技术指导原则》解读,探讨稳定性研究设计与评价中的若干问题。

The design and evaluation of drug stability are very important in the RD of new drug products and generic drugs.The scientific protocol for the stability design of drug products is fundamental in technical evaluation in the area of drug review.Base on the guidance of SFDA,the concerns about drug stability research were interpreted thoroughly in this article.