Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations.
Clin Transl Sci
; 17(5): e13819, 2024 May.
Article
en En
| MEDLINE
| ID: mdl-38747478
ABSTRACT
The equivalence of absorption rates and extents between generic drugs and their reference formulations is crucial for ensuring therapeutic comparability. Bioequivalence (BE) studies are widely utilized and play a pivotal role in substantiating the approval and promotional efforts for generic drugs. Virtual BE simulation is a valuable tool for mitigating risks and guiding clinical BE studies, thereby minimizing redundant in vivo BE assessments. Herein, we successfully developed a physiologically based absorption model for virtual BE simulations, which precisely predicts the BE of the apixaban test and reference formulations. The modeling results confirm that the test and reference formulations were bioequivalent under both fasted and fed conditions, consistent with clinical studies. This highlights the efficacy of physiologically based absorption modeling as a powerful tool for formulation screening and can be adopted as a methodological and risk assessment strategy to detect potential clinical BE risks.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Pirazoles
/
Piridonas
/
Equivalencia Terapéutica
/
Modelos Biológicos
Límite:
Humans
/
Male
Idioma:
En
Revista:
Clin Transl Sci
Año:
2024
Tipo del documento:
Article
País de afiliación:
China