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Food Effect in Humans: Predicting the Risk Through In Vitro Dissolution and In Vivo Pharmacokinetic Models

In vitro and in vivo experimental models are frequently used to assess a new chemical entity’s (NCE) biopharmaceutical performance risk for food effect (FE) in humans. Their ability to predict human FE hinges on replicating key features of clinical FE studies and building an in vitro-in vivo relatio...

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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Mathias, Neil, Xu, Yan, Vig, Balvinder, Kestur, Umesh, Saari, Amy, Crison, John, Desai, Divyakant, Vanarase, Aditya, Hussain, Munir
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2015
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4476984/
https://ncbi.nlm.nih.gov/pubmed/25933598
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9759-z
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