创新性药物研发过程中药学变更的相关考虑

摘要

As the CMC development and research of innovative drugs have the characteristics of uncertainty and phased approach, a lot of CMC changes took place during drug development. Here, the common reasons for change, review focus on change, main change types and technical requirements for each change type were summarized. Furthermore, typical cases were used to elaborate the concepts above.%由于创新性药物药学研究具有渐进性和不确定性,决定了其研究进程中必然存在各种变更.本文总结了创新性药物研发过程中药学变更的常见原因、评价核心、主要变更类型、各类变更的技术考虑要点,并以实例对研究思路做了进一步阐述.