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 III (high solubility and low permeability) compounds.

 

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The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers
Alan Parr1 & Ismael J. Hidalgo2 & Chris Bode2 & William Brown3 & Mehran Yazdanian4 & Mario A. Gonzalez5 & Kazuko Sagawa6 &
Kevin Miller1 & Wenlei Jiang7 & Erika S. Stippler3
Pharm Res (2016) 33:167–176
DOI 10.1007/s11095-015-1773-4
The Effect of Excipients on the Permeabi
Adobe Acrobat Document 529.3 KB