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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...
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| Publicado no: | Saudi Pharm J |
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| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Elsevier
2017
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5355546/ https://ncbi.nlm.nih.gov/pubmed/28344480 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.jsps.2016.07.005 |
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