胰岛素类产品药学研究基本技术要求的考虑

Consideration of basic technical requirements for pharmaceutical research of insulin and its analogues

本文根据近几年胰岛素类产品的申报情况和审评中的常见问题,结合国内外相关法规及通用技术指导原则,对胰岛素类产品药学研究的基本技术要求进行了梳理,对胰岛素类产品的药学基本技术要求和评价重点关注问题进行了讨论分析。

In this paper,the basic technical requirements for pharmaceutical research of insulin and its analogues are sorted out according to the application and review of insulin and its analogues in recent years,combined with the relevant laws and regulations local and abroad and the general technical guidelines. Pharmaceutical technical requirements and key issues in the evaluation of insulin and its analogues were discussed and analyzed.