Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission

Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission

Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutical Sciences - Volume 111, 1 January 2018, Pages 399-408

J.-M. Cardot, A. Garcia-Arieta, P. Paixao, I. Tasevska, B. Davit,