试验室两阶段一个隔间倾销试验数据和吸收/配方 PBBM 建模,以解释瓦尔萨坦配方的生物等价性失败
Bárbara Sánchez-Dengra1, Alejandro Ruiz-Picazo1, Isabel Gonzalez-Alvarez1
1Pharmacokinetics and Pharmaceutical Technology Area. Miguel Hernandez University, Spain.
概括
一种简化的"倾销试验"溶解方法有效地预测了制药配方的体内生物等价性. 这种具有成本效益的方法可以建立可靠的体外-体内相关性 (IVIVC) 和基于生理学的生物制药模型 (PBBM).
科学领域:
- 制药科学 制药科学
- 药物输送和配方 药物输送和配方
- 生物制药生物制药公司
背景情况:
- 开发预测性溶解方法对于体外-体内相关性 (IVIVC) 和生物预测模型至关重要.
- 现有的方法通常依赖于复杂,昂贵的模拟人类生理学的设备.
- 这项研究旨在使用简化动态溶解技术预测体内生物等价性 (BE).
研究的目的:
- 使用简化动态溶解方法来预测体内生物等价性 (BE).
- 建立一个基于生理学的生物制药模型 (PBBM).
- 为了评估沙坦 (BCS Class IV) 和化 (BCS Class III) 的口服固定剂量组合.
主要方法:
- 为了评估药物释放概况,应用了一种两阶段的,单间溶解技术,即"倾销测试",用于评估药物释放概况.
- 实验室溶解数据被纳入了一个基于生理学的生物制药模型 (PBBM).
- 使用两个缩放因子 (时间和吸收) 来提高 PBBM 的预测准确度.
主要成果:
- "倾销测试"成功模拟了各种溶解行为,并解释了生物等价性失败.
- 建立的体外-体内相关性 (IVIVC) 证明了有效性和生物预测能力.
- 基于生理学的生物制药模型 (PBBM) 预测错误仍在可接受的监管范围内.
结论:
- 一种简单的动态溶解方法,即"倾销试验",可以有效地预测体内生物等价性.
- 这种方法为配方溶解特性提供了宝贵的见解.
- "倾销测试"是生物预测研究的成本效益高且实用的工具.
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