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SearchBE of parenterals [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2018-10-08 09:53 – Posting: # 19416
Views: 1,100
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.
» 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.
—
Cheers,
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. ☼
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Cheers,
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 parenterals Helmut 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