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

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...

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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.
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