fedesalas
☆    

Costa Rica,
2018-09-12 15:46

Posting: # 19279
Views: 1,090
 

 Bio Batch Size [Design Issues]

Dear all,

The EMA says about the bio batch:

"Test product
The test product used in the study should be representative of the product to be marketed and this
should be discussed and justified by the applicant.
For example, for oral solid forms for systemic action:
a) The test product should usually originate from a batch of at least 1/10 of production scale or
100,000 units, whichever is greater, unless otherwise justified."


But if the bio batch used in the BE study was lower than 100 000 tablets, in what way we can justify this?
Ohlbe
★★★

France,
2018-09-12 22:19

@ fedesalas
Posting: # 19283
Views: 961
 

 Bio Batch Size

Dear fedesalas,

» For example, for oral solid forms for systemic action:
» a) The test product should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified."
»
» But if the bio batch used in the BE study was lower than 100 000 tablets, in what way we can justify this?

If the intended production batch size is smaller than 100,000 units, then you have to use a full size batch. This may happen for drugs with a very small market: if you plan to have a production batch size of 50,000 because the sales are very limited (orphan drug product), then use this for your biobatch.

If the expected sales are millions of tablets per year, don't even think of claiming a batch size of 50,000 because that's what you used in your BE. It won't work. The Agencies won't believe you and your dossier is likely to get rejected. If the study has already been performed: too bad. Too late. The justification should come before the trial, not after...

Regards
Ohlbe
Imadov
☆    

Saudi Arabia,
2019-05-11 09:43

@ fedesalas
Posting: # 20278
Views: 186
 

 Bio Batch Size

» The test product used in the study should be representative of the product to be marketed for oral solid forms for systemic action:
» The test product should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified."

The question is :

If we prepare a Qty of granules of bio-batch equivalent to 100 000 finished product units and compress only about 30 % of the final blend of granules Qty ( means to get about 30 000 to 35 000 tablets without completing the compression stage with continuing the film coating and the other QC testing for the produced tablets )

Can we consider this compressed Qty as a representative batch and justified to be used in the Bio-Equivalency study ?

Thanks


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]
wienui
★    

Germany, Oman,
2019-05-11 13:27
(edited by wienui on 2019-05-11 18:29)

@ Imadov
Posting: # 20279
Views: 178
 

 Bio Batch Size

Dear Imad(ov),

» The question is :
»
» If we prepare a Qty of granules of bio-batch equivalent to 100 000 finished product units and compress only about 30 % of the final blend of granules Qty ( means to get about 30 000 to 35 000 tablets without completing the compression stage with continuing the film coating and the other QC testing for the produced tablets )
»
» Can we consider this compressed Qty as a representative batch and justified to be used in the Bio-Equivalency study ?

The EMA GL says the test biobatch should be representative of the product to be marketed which is in this case 30 000 to 35 000 tablets (lower than 100.000 units) and don't say representative of the product to be produced, therefore the answer of your question is: you can't.
As long as the biobatch is less than 100.000 then scaling up is not allowed.

Best regards,

Osama
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