Bioequivalence and Bioavailability Forum • BE of parenterals

BE of parenterals [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2018-10-08 09:53 (880 d 13:51 ago) – Posting: # 19416
Views: 2,460

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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Complete thread:

Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-08 11:34 [Regulatives / Guidelines]
- BE of parenteralsHelmut 2018-10-08 11:53
- Enoxaparin sodium injection BA BE studies nobody 2018-10-09 10:42
  - Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-10 07:09
- Enoxaparin sodium injection BA BE studies ElMaestro 2018-10-09 11:13
  - Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-10 07:11