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Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission
Cardot, J.-M., Garcia Arieta, A., Paixao, P., Tasevska, I., Davit, B.Langue:
english
Journal:
European Journal of Pharmaceutical Sciences
DOI:
10.1016/j.ejps.2017.10.013
Date:
October, 2017
Fichier:
PDF, 825 KB
english, 2017