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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Detalles Bibliográficos
Autores principales: Refalo, Nathaniel, Chetcuti, Daniel, Tanti, Amy, Serracino-Inglott, Anthony, Borg, John Joseph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2017
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5355546/
https://www.ncbi.nlm.nih.gov/pubmed/28344480
http://dx.doi.org/10.1016/j.jsps.2016.07.005

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5355546/
https://www.ncbi.nlm.nih.gov/pubmed/28344480
http://dx.doi.org/10.1016/j.jsps.2016.07.005

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