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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Elsevier
2017
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| Materias: | |
| 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 |