Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Post-approval changes bioequivalence studies

Waiver of in vivo bioequivalence studies for major post approval manufacturing changes for the BCS Class I (Biopharmaceutics Classification System highly soluble, highly permeable and rapidly dissolving) solid oral products is NOT recommended for narrow therapeutic index drugs (17). [Pg.504]

See other pages where Post-approval changes bioequivalence studies is mentioned: [Pg.514]    [Pg.31]    [Pg.33]    [Pg.286]    [Pg.352]    [Pg.396]    [Pg.23]    [Pg.144]    [Pg.147]    [Pg.524]    [Pg.392]    [Pg.263]    [Pg.428]   
See also in sourсe #XX -- [ Pg.136 , Pg.144 , Pg.147 ]



SEARCH



Bioequivalence studies

Bioequivalency

Chang studies

Post-approval changes

© 2024 chempedia.info