中国合理用药探索2025，Vol.22Issue(8)：24-32,9.DOI:10.3969/j.issn.2096-3327.2025.08.003
癌症用药开发中的剂量优化
Dose Optimization in Oncology Drug Development
姚立新1
作者信息
- 1. 国家药品监督管理局南方医药经济研究所,广州 510080
- 折叠
摘要
Abstract
The dose selection of traditional oncology drug is typically based on the maximum tolerated dose(MTD)principle,which is suitable for cytotoxic drugs with a steep dose-response relationship.However,with the emergence of novel anticancer drugs such as targeted therapy and immunotherapy,the MTD model is no longer applicable—higher doses may increase toxicity without significantly improving efficacy.To address this issue,the U.S.Food and Drug Administration(FDA)has established Project Optimus through public-private partnerships,providing a toolkit for dose optimization in oncology drug development and formulating industry guidelines for dose optimization tailored to the specific context of individual oncology drug.This aims to establish more scientific and precise criteria for dose selection in oncology drug development.关键词
剂量优化/最大耐受剂量/剂量-响应/Optimus计划/个体化医疗Key words
dose optimization/maximum tolerated dose/dose-response/Project Optimus/personalized medicine分类
医药卫生引用本文复制引用
姚立新..癌症用药开发中的剂量优化[J].中国合理用药探索,2025,22(8):24-32,9.
