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RegisterBE of parenterals [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2018-10-08 13:53 (2464 d 09:00 ago) – Posting: # 19416
Views: 4,269
Hi Varsha,
It’s not that simple. See e.g., the EMA’s GL page 23.
That’s not the point. See the FDA’s guidance for conditions whether the in vivo PD (!) study can be waived.
Differ to what? To get an idea, see the EMA’s guidelines on biosimilars.
❝ 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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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-08 11:34 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
Ing. Helmut Schütz