对产生和验证生理学基础药理动力学模型虚拟群体的方法进行批判性审查:方法,案例研究和前进的方法
Mahendra Chougule1, Sivacharan Kollipara1, Smritilekha Mondal1
1Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, 500 090, Telangana, India.
European journal of clinical pharmacology
|October 8, 2024
概括
虚拟生物等价利用生理学基础的药物动力学 (PBPK) 和生物制药模型 (PBBM) 来预测药物配方等价性. 优化虚拟人群是减少人类研究和确保可靠的生理模型的关键.
科学领域:
- 药物动力学和生物制药学
- 计算机建模和模拟
背景情况:
- 基于生理学的药理动力学 (PBPK) 和基于生理学的生物制药模型 (PBBM) 在药物发现中至关重要.
- 使用这些工具的虚拟生物等价性可以减少对人类临床研究的需求.
研究的目的:
- 描述优化虚拟种群以实现虚拟生物等价性的方法.
- 确保验证的虚拟种群准确地反映了体内生物的变异性.
主要方法:
- 使用物理化学,生理学和处置因素,为虚拟群体展示了优化策略.
- 使用了六个立即释放和修改释放配方的案例研究.
- 雇佣了Gastroplus软件用于虚拟人口优化.
主要成果:
- 描述了专注于特定和敏感参数的优化策略.
- 阐明了研究设计,体内可变性和样本大小的考虑因素.
- 从Gastroplus的角度展示了虚拟人口优化.
结论:
- 为虚拟人口优化提供了一步一步的流程.
- 旨在确保生物制药科学家可靠和可信的生理模型.
- 促进了在药物开发中虚拟生物等效的应用.
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