奥夫洛克萨的综合生理学基础的药代动力学框架:预测功能障碍的处置
Ammara Zamir1, Muhammad Fawad Rasool1, Iltaf Hussain2
1Department of Pharmacy Practice, Faculty of Pharmacy, Bahauddin Zakariya University, Multan 60800, Pakistan.
Pharmaceutics
|September 27, 2025
概括
基于生理学的药理动力学 (PBPK) 建模用于分析健康个体和功能障碍 (RI) 患者的欧洛素药理动力学. 这种PBPK模型有助于优化不同患者群体的奥洛素剂量.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药理动力学 药理动力学
- 药物新陈代谢 药物新陈代谢
背景情况:
- 基于生理学的药理动力学 (PBPK) 建模越来越多地强调药物吸收,处置和新陈代谢.
- 了解洛克萨的药理动力学 (PK) 是至关重要的,特别是在有改变生理状态的人群中.
研究的目的:
- 开发PBPK模型用于健康受试者和功能障碍 (RI) 患者的奥洛素.
- 为了表征血/血清度-时间概况和ofloxacin的PK参数.
主要方法:
- 在PK-Sim®软件中实现的ofloxacin PK数据的文献分析.
- 在健康人群中开发PBPK模型 (IV和PO路径) 和推断到RI人群.
- 模型评估使用指标,如预测/观察比率,视觉预测检查,AFE,RMSE和MAE用于Cmax,AUC0-t和CL.
主要成果:
- 在RI患者中,PBPK模型显示了可接受的Cmax精度 (AFE=1.10,RMSE=0.22,MAE=0.16).
- 盒子胡须图表说明了对轻度,中度和重度RI所需的剂量调整,并比较了健康个体的全身暴露.
结论:
- PBPK模型的预测证实了RI群体中洛的显著PK变异.
- 开发的PBPK模型可以帮助临床医生优化ofloxacin剂量方案,无论是健康患者还是功能受损患者.
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