Predicting Bioequivalence and Developing Dissolution Bioequivalence Safe Space in vitro for Warfarin using a Physiologically-Based Pharmacokinetic Absorption Model.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V（2023）
摘要
The results revealed that the PBPK models were successfully developed for 2.5 mg of warfarin sodium tablets in Chinese individuals. Developing a PBPK model for NTI drugs based on in vitro dissolution data in software is a promising method for BE evaluation, which can provide great help for developing new drugs and the clinical trial research of BE of generic drugs.
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关键词
Generic drugs,NTI drugs,Bioequivalence,Warfarin,Physiologically-based pharmacokinetic (PBPK) model
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