Assessing Bioequivalence of Antiepileptic Drugs: Are the Current Requirements too Permissive?

Purpose: In order to evaluate the permissiveness of current bioequivalence requirements for antiepileptic drugs we investigated how accurate Cmax and AUC0-t of generic antiepileptic drugs approved in Brazil are in comparison to reference products. Methods: Data collected from assessment reports of...

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Bibliographic Details
Main Authors: Camila F Rediguieri, Jorge L Zeredo
Format: Article
Language:English
Published: Canadian Society for Pharmaceutical Sciences 2014-05-01
Series:Journal of Pharmacy & Pharmaceutical Sciences
Online Access:https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/21116