在瘤学中剂量优化 药物开发:在药物开发中创新和质量的国际联盟 白皮书
Divya Samineni1, Karthik Venkatakrishnan2, Ahmed A Othman3
1Genentech, Inc., South San Francisco, California, USA.
Clinical pharmacology and therapeutics
|May 16, 2024
概括
项目Optimus旨在改革瘤学药物剂量. 一个工作组建议根据具体因素来优化癌症药物剂量的个案方法,以获得更好的疗效.
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:
- 瘤学药物开发取得了重大进展,改善了患者的治疗结果.
- 传统的最大耐受剂量 (MTD) 选择对于新疗法来说是不够的.
- 美国食品和药物管理局的"最佳项目"旨在改革瘤药物剂量选择.
研究的目的:
- 解决瘤药物开发中的复杂剂量优化挑战.
- 描述目前在瘤学中优化剂量的行业实践.
- 为改善剂量选择提供建议和开发工具包.
主要方法:
- 形成一个瘤学剂量优化智商工作组.
- 对会员公司进行关于行业实践的调查.
- 分析影响剂量优化策略的因素.
主要成果:
- 收集了有关瘤学剂量优化的行业实践.
- 需要从MTD转向量身定制的剂量选择.
- 为优化剂量方案,建议采用个别案例的方法.
结论:
- 瘤药物开发需要多维优化.
- 针对性,基于证据的方法对于有效的剂量优化至关重要.
- 与卫生当局的合作对于实施新战略至关重要.
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