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Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling

While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration of pre-existing data on systems and drugs is growing from its infancy, building confidence on VBE outcomes requires demonstration of its ability not only in predicting formulation-dep...

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Detalles Bibliográficos
Autores principales: Bego, Margareta, Patel, Nikunjkumar, Cristofoletti, Rodrigo, Rostami-Hodjegan, Amin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8817238/
https://www.ncbi.nlm.nih.gov/pubmed/34988679
http://dx.doi.org/10.1208/s12248-021-00672-z