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Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics – a case study and utility in regulatory justifications
Xenobiotica ( IF 1.8 ) Pub Date : 2023-12-19 , DOI: 10.1080/00498254.2023.2289160
Rajkumar Boddu 1 , Sivacharan Kollipara 1 , Adithya Karthik Bhattiprolu 1 , Tausif Ahmed 1
Affiliation  

Physiologically based biopharmaceutics modelling (PBBM) was recognised as potential approach for biopharmaceutics applications. However, PBBM to justify safety is an unexplored area.In this manusc...

中文翻译:

PBBM 的新应用证明更快溶出对安全性和药代动力学的影响——案例研究和监管理由的实用性

基于生理学的生物制药模型(PBBM)被认为是生物制药应用的潜在方法。然而,证明安全性的 PBBM 是一个尚未探索的领域。在本手册中...
更新日期:2023-12-24
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