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

• Main Authors: Nathaniel Refalo (Author), Daniel Chetcuti (Author), Amy Tanti (Author), Anthony Serracino-Inglott (Author), John Joseph Borg (Author)
• Formato: Livro
• Publicado em: Elsevier, 2017-02-01T00:00:00Z.
• Assuntos: article
• Acesso em linha: 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...