varsha chungde
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India,
2018-10-08 11:34
(750 d 22:44 ago)

Posting: # 19415
Views: 2,562
 

 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
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Vienna, Austria,
2018-10-08 11:53
(750 d 22:26 ago)

@ varsha chungde
Posting: # 19416
Views: 2,317
 

 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.

Dif-tor heh smusma 🖖
Helmut Schütz
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nobody
nothing

2018-10-09 10:42
(749 d 23:36 ago)

@ varsha chungde
Posting: # 19418
Views: 2,203
 

 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
☆    

India,
2018-10-10 07:09
(749 d 03:09 ago)

@ nobody
Posting: # 19423
Views: 2,128
 

 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The draft guidance says that we need to prove the sameness between API.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
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Belgium?,
2018-10-09 11:13
(749 d 23:06 ago)

@ varsha chungde
Posting: # 19419
Views: 2,205
 

 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

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
varsha chungde
☆    

India,
2018-10-10 07:11
(749 d 03:07 ago)

@ ElMaestro
Posting: # 19424
Views: 2,151
 

 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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