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pro vyhledávání: '"Ines Lenić"'
Publikováno v:
Clinical and Translational Science, Vol 12, Iss 5, Pp 490-496 (2019)
The waiver of the in vivo demonstration of bioequivalence (biowaiver) is an established tool in drug development and regulatory assessment. This study reviews the use of different biowaiver approaches in centralized applications for marketing authori
Externí odkaz:
https://doaj.org/article/0bb60b2ea71e4f289177e8a2d1c105b3