在癌症药物开发中的剂量优化:多方利益相关者研讨会的审查和结果
Axel Glasmacher1, Elena Garralda2, Chad Gwaltney3
1Cancer Drug Development Forum (CDDF) asbl, Brussels Life Science Incubator, Clos Chapelle-aux-Champs 30, Bt 1.30.30, 1200 Woluwe Saint Lambert, Belgium; Dep. of Internal Medicine III, Universitätsklinikum Bonn, Venusberg-Campus 1, Bonn 53127, Germany.
优化癌症药物剂量对于更好的治疗结果至关重要. 建议在向治疗和免疫治疗中采用一种新的方法,从临床前阶段开始,并使用剂量反应数据.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
背景情况:
- 癌症治疗的低于最佳剂量可以降低疗效,增加毒性,减少患者的益处.
- 传统的最大耐受剂量 (MTD) 方法对于新型向疗法和免疫疗法是不够的.
- 监管机构越来越多地支持优化剂量确定策略.
研究的目的:
- 建议在瘤药物开发中进行剂量优化的修订范式.
- 强调早期的剂量考虑和最佳生物剂量的使用.
- 根据多方利益相关者研讨会提供建议.
主要方法:
- 对现代癌症疗法的当前剂量发现限制的审查.
- 对癌症药物开发论坛研讨会建议的分析.
- 建议将剂量优化从临床前阶段整合到临床阶段.
主要成果:
- 剂量优化应该从临床前阶段开始,考虑模型和治疗目标.
- 临床试验必须描述剂量反应曲线,并尽早确定潜在的剂量.
- 剂量选择应基于证据,理想情况下使用随机研究.
结论:
- 现代瘤学药物需要转向最佳的生物剂量.
- 实施新的剂量确定模式需要利益相关者之间的合作.
- 采用这些建议将提高患者护理,赞助商效率和医疗保健提供者的结果.
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