Pioneering access to complex generic productsÂ
Drug Discovery World
AUGUST 22, 2023
In many cases, it is also challenging to apply traditional bioequivalence methods or to ensure clarity about the comparison model (in-vitro/in-vivo) needed to gain health authority approval. When it comes to peptides, more than 80 were approved in the US alone, with 8% of FDA branded drug approvals being for peptides during 2016-2021.
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