一个智商行业的观点,以告知患有功能障碍的患者的剂量建议
Ashish Sharma1, Islam R Younis2, Jitendra Kanodia3
1Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA.
Clinical pharmacology and therapeutics
|October 23, 2024
概括
制药公司缺乏统一的方法来评估药物开发中的功能. 然而,基于模型的方法的进步改善了对功能对药物药理动力学 (PK) 影响的预测,使得更好的剂量建议成为可能.
科学领域:
- 药理动力学和药物开发
- 功能障碍研究 功能障碍研究
- 药学研究 药学研究
背景情况:
- 对患有功能障碍的患者来说,评估药物剂量至关重要.
- 现有的监管指南和行业出版物为剂量策略提供了信息.
- 制药公司如何对待功能障碍评估存在变化.
研究的目的:
- 对IQ会员公司进行调查,了解他们制定功能障碍剂量建议的方法.
- 确定药物开发过程中评估功能时的当前做法和挑战.
- 了解最近进展对预测功能对药理动力学影响的影响.
主要方法:
- 在18家IQ会员公司中进行了一项调查.
- 在监管指导和科学文献的背景下分析了结果.
- 专注于评估功能和预测药理动力学变化的方法.
主要成果:
- 制药公司在评估功能方面没有采用一致的方法.
- 在预测功能如何影响药物药理动力学 (PK) 方面取得了显著的改进.
- 基于模型的方法,如人口PK,PBPK和虚拟控制,有助于更早的预测.
结论:
- 在药物开发中,对功能评估的不一致的方法仍然存在.
- 基于模型的方法可以更好地预测功能障碍对PK和剂量的影响.
- 这些进展使得更早的预测和功能障碍患者在临床试验中的参与增加.
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