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This paper was written partly based on the discussions from an Open Forum held at the 2010 PSWC/AAPS Annual Meeting, New Orleans. The opinions expressed in this article do not necessarily represent the views or policies of the U.S. Food and Drug Administration.
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Chen, ML., Amidon, G.L., Benet, L.Z. et al. The BCS, BDDCS, and Regulatory Guidances. Pharm Res 28, 1774–1778 (2011). https://doi.org/10.1007/s11095-011-0438-1
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DOI: https://doi.org/10.1007/s11095-011-0438-1