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Updated: Jul 26, 2025

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简化食品影响评估 - - 需要重复食品影响研究吗? 一个智商分析分析
Filippos Kesisoglou1, Sumit Basu2, Tejashree Belubbi3
1Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ, USA. Filippos_kesisoglou@merck.com.
The AAPS journal
|June 15, 2023
概括
大多数重复的药物与食物相互作用研究显示,无论配方调整,食物效果的变化最小. 基于生理学上的药理动力学 (PBPK) 建模可以帮助预测结果,建议对这些研究进行个案评估.
科学领域:
- 药理动力学和药物开发
- 监管科学 监管科学
背景情况:
- 目前的指导方针要求对药物与食品相互作用进行早期和关键的食物效应研究.
- 在药物开发中,重复的食物效应研究是常见的,但数据很少.
- 研究豁免仅限于BCS第1类药物.
研究的目的:
- 收集药品公司对重复食品效应研究的数据.
- 为进行这些研究提供建议.
- 分析配方变化对食品效应的影响.
主要方法:
- 来自54项重复食品影响研究的数据集的编制.
- 分析食物效应的变化及其与配方变化的关系.
- 对未来配方的生理学基础药理动力学 (PBPK) 模型应用的演示.
主要成果:
- 大多数重复的食物影响研究 (54项收集) 在食品影响评估中没有显著差异.
- 观察到的食物效应的变化很少大于两倍.
- 在配方变化和食物效果的改变之间没有发现明确的联系,这表明化合物特性是关键的.
结论:
- 重复食品效应研究往往会产生与初步评估相似的结果.
- 一旦经过验证,生理学基础的药理动力学 (PBPK) 模型可以应用于新配方.
- 建议有利于重复食品效应研究的个案方法,整合所有证据,包括PBPK建模.
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