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varsha chungde
Junior

India,
2018-10-08 11:34

Posting: # 19415
Views: 348
 

 Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

Hi all,

As per guideline we need not to perform any Bioequivalence studies for Injectables. But Enoxaparin sodium being a biologically derived product, is there any need of performing the BA-BE studies.

Does the guideline differs for a biologically derived product?:confused::confused:confused:
Helmut
Hero
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Homepage
Vienna, Austria,
2018-10-08 11:53

@ varsha chungde
Posting: # 19416
Views: 334
 

 BE of parenterals

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.

Cheers,
Helmut Schütz
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nobody
Senior

2018-10-09 10:42

@ varsha chungde
Posting: # 19418
Views: 210
 

 Enoxaparin sodium injection BA BE studies

» As per guideline we need not to perform any Bioequivalence studies for Injectables.

That's simply not true at all.

There is a (draft) US guidance on BE for enoxaparine. Good starting point. Have fun!

Kindest regards, nobody
varsha chungde
Junior

India,
2018-10-10 07:09

@ nobody
Posting: # 19423
Views: 170
 

 Enoxaparin sodium injection BA BE studies

» There is a (draft) US guidance on BE for enoxaparine. Good starting point. Have fun!

The draft guidance says that we need to prove the sameness between API.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
ElMaestro
Hero

Denmark,
2018-10-09 11:13

@ varsha chungde
Posting: # 19419
Views: 204
 

 Enoxaparin sodium injection BA BE studies

Hello varsha,

» As per guideline we need not to perform any Bioequivalence studies for Injectables.

You mean solutions. :-D

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
varsha chungde
Junior

India,
2018-10-10 07:11

@ ElMaestro
Posting: # 19424
Views: 172
 

 Enoxaparin sodium injection BA BE studies

» You mean solutions. :-D

Yes i mean injectable aqueous solution. As enoxaparin injection is API in aqueous solution. But enoxaparin being a biotech product, i just needed an clarification. Do we need to prove our AP to be similar or good enough to waive the BE studies.


Edit 2018-10-10 07:14: The draft guidance also says to prove the sameness of API. [Varsha]


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Merged with a later (deleted) post. You can edit your post within 24 hours. [Helmut]
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