Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective

• Auteurs principaux: Nathaniel Refalo (Auteur), Daniel Chetcuti (Auteur), Amy Tanti (Auteur), Anthony Serracino-Inglott (Auteur), John Joseph Borg (Auteur)
• Format: Livre
• Publié: Elsevier, 2017-02-01T00:00:00Z.
• Sujets: article
• Accès en ligne: Connect to this object online.

Background: The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a m...