Similar biological medicinal products containing recombinant follicle-stimulating hormone - Scientific guideline

This document lays down the non-clinical and clinical requirements for recombinant human follicle stimulating hormone (r-hFSH)-containing medicinal products claiming to be similar to another one already marketed.

Keywords: Follicle stimulating hormone (FSH), similar biological products, comparability, non-clinical studies, clinical studies

Document history - First version (current)


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