The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers

PURPOSE: Currently, the FDA allows biowaivers for Class I (high solubility and high permeability) and Class III (high solubility and low permeability) compounds of the Biopharmaceutics Classification System (BCS). Scientific evidence should be provided to support biowaivers for BCS Class I and Class...

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Detalles Bibliográficos
Autores principales: Parr, Alan, Hidalgo, Ismael J., Bode, Chris, Brown, William, Yazdanian, Mehran, Gonzalez, Mario A., Sagawa, Kazuko, Miller, Kevin, Jiang, Wenlei, Stippler, Erika S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2015
Materias:
Research Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4689772/
https://www.ncbi.nlm.nih.gov/pubmed/26286187
http://dx.doi.org/10.1007/s11095-015-1773-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4689772/
https://www.ncbi.nlm.nih.gov/pubmed/26286187
http://dx.doi.org/10.1007/s11095-015-1773-4

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