翻译性PK/PD:对药物组合的性能和影响进行了回顾性分析
Rasmus Jansson-Löfmark1, Markus Fridén2, Lassina Badolo3
1Research and Early Development Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
翻译性药理动力学/药理动力学 (PK/PD) 建模准确地预测了药物证明机制 (PoM). 强大的PK/PD套餐显著提高了临床试验成功率,减少了药物开发磨损.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
- 翻译医学是一种翻译医学.
背景情况:
- 临床试验的消耗,特别是在中期研究中,仍然是药物开发的一个重大挑战.
- 证明证明机制 (PoM) 对于提高临床成功率至关重要.
- 准确的PoM预测和测试对于有效的药物开发至关重要.
研究的目的:
- 评估翻译性药理动力学/药理动力学 (PK/PD) 建模在预测AstraZeneca药物开发组合中的临床PoM中的作用.
- 评估PK/PD建模包稳定性对PoM成功率的影响.
主要方法:
- 对AstraZeneca的复合组合组合进行分析,重点关注翻译性PK/PD建模.
- 评估药物暴露-反应关系和预测准确性.
- 强大的项目与基本的PK/PD包之间的PoM成功率的比较.
主要成果:
- 83%的分析化合物显示药物暴露-反应在使用PK/PD建模的三倍预测准确度内.
- 具有强大的PK/PD包的项目在PoM中实现了85%的成功率.
- 具有基本PK/PD包的项目具有显著较低的PoM成功率,为33%.
结论:
- 翻译性PK/PD建模是预测临床证明机制的强大工具.
- 强大的PK/PD建模包与较高的PoM成功率密切相关.
- 实施先进的PK/PD建模可以显著提高药物开发的成功率,并减少药物流失.
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