BE of parenterals [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-10-08 09:53 (986 d 03:02 ago) – Posting: # 19416
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Hi Varsha,

» As per guideline we need not to perform any Bioequivalence studies for Injectables.
It’s not that simple. See e.g., the EMA’s GL page 23.

» But Enoxaparin sodium being a biologically derived product, is there any need of performing the BA-BE studies.
That’s not the point. See the FDA’s guidance for conditions whether the in vivo PD (!) study can be waived.

» Does the guideline differs for a biologically derived product?
Differ to what? To get an idea, see the EMA’s guidelines on biosimilars.
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