varsha chungde
☆    

India,
2018-10-08 13:34
(2466 d 23:32 ago)

Posting: # 19415
Views: 4,823
 

 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
★★★
avatar
Homepage
Vienna, Austria,
2018-10-08 13:53
(2466 d 23:14 ago)

@ varsha chungde
Posting: # 19416
Views: 4,276
 

 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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
nobody
nothing

2018-10-09 12:42
(2466 d 00:24 ago)

@ varsha chungde
Posting: # 19418
Views: 4,136
 

 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 09:09
(2465 d 03:57 ago)

@ nobody
Posting: # 19423
Views: 4,061
 

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The draft guidance says that we need to prove the sameness between API.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

Denmark,
2018-10-09 13:13
(2465 d 23:54 ago)

@ varsha chungde
Posting: # 19419
Views: 4,149
 

 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

Pass or fail!
ElMaestro
varsha chungde
☆    

India,
2018-10-10 09:11
(2465 d 03:55 ago)

@ ElMaestro
Posting: # 19424
Views: 4,070
 

 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]
UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,684 registered users;
28 visitors (0 registered, 28 guests [including 7 identified bots]).
Forum time: 13:07 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5