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Integrating In Vitro, Modeling, and In Vivo Approaches to Investigate Warfarin Bioequivalence

We demonstrate the use of modeling and simulation to investigate bioequivalence (BE) concerns raised about generic warfarin products. To test the hypothesis that the loss of isopropyl alcohol and slow dissolution in acidic pH has significant impact on the pharmacokinetics of warfarin sodium tablets,...

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Detalles Bibliográficos
Autores principales: Zhang, X, Wen, H, Fan, J, Vince, B, Li, T, Gao, W, Kinjo, M, Brown, J, Sun, W, Jiang, W, Lionberger, R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572358/
https://www.ncbi.nlm.nih.gov/pubmed/28379643
http://dx.doi.org/10.1002/psp4.12198