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从实验室到诊所,以模型为基础的配方开发:氧SR片的案例研究

Aditya Murthy1, Shubham Jamdade1, Manoj Gundeti1

  • 1Biopharmaceutics, Global Clinical Management, Dr Reddy's Laboratories Ltd, Hyderabad, India.

Xenobiotica; the fate of foreign compounds in biological systems
|April 25, 2025
PubMed
概括

模型知情配方开发 (MIFD) 使用生理学基础的药理动力学 (PBPK) 建模来创建持续释放的氧配方. 这种方法成功地降低了度的峰值,并通过生物等价性研究证实了有效性.

关键词:
在 GastroPlusTM 建模中使用 GastroPlusTM 模型.生物等价性 生物等价性有控制释放的释放.不同的产品是不同的产品.溶解溶解是一种食物的作用 (s)在体外/体内 (IVIVC) 相关性基于模型的配方开发 (MIFD)基于生理学的药理动力学 (PBPK) 建模.

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