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Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
Pharmaceutical Research ( IF 3.5 ) Pub Date : 2022-09-02 , DOI: 10.1007/s11095-022-03380-1 Timothy Qi 1 , Tyler Dunlap 1 , Yanguang Cao 1, 2
中文翻译:
拥抱 Project Optimus:我们可以利用进化论来优化肿瘤学的剂量吗?
更新日期:2022-09-04
Pharmaceutical Research ( IF 3.5 ) Pub Date : 2022-09-02 , DOI: 10.1007/s11095-022-03380-1 Timothy Qi 1 , Tyler Dunlap 1 , Yanguang Cao 1, 2
Affiliation
Project Optimus is a US Food and Drug Administration (FDA) initiative to reform dose selection in oncology drug development. Here, we focus on tumor evolution, a broadly observed phenomenon that invariably leads to therapeutic failure and disease relapse, and its effect on the exposure–response (E-R) relationships of oncology drugs. We propose a greater emphasis on tumor evolution during clinical development to facilitate the selection of optimal doses for molecularly targeted therapies and immunotherapies in oncology.
中文翻译:
拥抱 Project Optimus:我们可以利用进化论来优化肿瘤学的剂量吗?
Optimus 项目是美国食品和药物管理局 (FDA) 发起的一项改革肿瘤药物开发剂量选择的倡议。在这里,我们关注肿瘤演变,这是一种广泛观察到的现象,总是导致治疗失败和疾病复发,以及它对肿瘤药物的暴露-反应 (ER) 关系的影响。我们建议在临床开发过程中更加强调肿瘤的演变,以促进选择最佳剂量用于肿瘤学中的分子靶向治疗和免疫治疗。