Business · 30/12/2003
FDA Releases Draft Guidance for Clozapine Tablets Bioequivalence Testing
The FDA has released a draft guidance for industry on designing bioequivalence studies for generic clozapine products, due to revised agency recommendations and the removal of in vivo testing in healthy subjects, following a 1996 guidance revision.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →