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Bioequivalence studies guidance documents

See the FDA guidance for industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (August 2000) at http //www.fda.gov/cvm/guidance/guidel71.pdf.This document provides complementary information on the Biopharmaceutics Classification System. [Pg.140]

The objective of this document is to provide guidance to organizations involved in the conduct and analysis of in vivo bioequivalence studies. [Pg.440]


See other pages where Bioequivalence studies guidance documents is mentioned: [Pg.352]    [Pg.9]    [Pg.524]    [Pg.1322]    [Pg.1785]    [Pg.3988]    [Pg.467]    [Pg.440]    [Pg.84]    [Pg.91]    [Pg.87]    [Pg.102]    [Pg.667]    [Pg.244]    [Pg.144]    [Pg.147]    [Pg.2]    [Pg.332]   
See also in sourсe #XX -- [ Pg.94 , Pg.265 ]




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