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Updated: Sep 19, 2025

Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
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Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles

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基于生理学的生物制药建模 (PBBM) 的应用,以建立临床相关的溶解规格,用于维拉帕米尔的延长释放片剂配方,这是BCS I类药物

Anagha Damre1, Aniruddha Banerjee2

  • 1DMPK, Global Preclinical & Product Safety, Product Innovation & Development, Established Pharmaceuticals, Abbott Healthcare Pvt. Ltd, Mumbai, 400093, India. anagha.damre@abbott.com.

AAPS PharmSciTech
|June 4, 2025
PubMed
概括

这项研究确定了使用体外-体内相关性 (IVIVC) 和生理学基础生物制药建模 (PBBM) 的维拉帕米尔延长释放配方的临床相关溶解规格. 这种方法支持生物等价性 (BE) 评估和批准后的变化.

关键词:
在体外-体内 (IVIVC) 的相关性 ().生物等效 (BE) 安全空间安全空间生物豁免 生物豁免临床相关的溶解规范.机械建模机械建模基于生理学的生物制药建模 (PBBM)

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