kiranActimus
Junior

India,
2011-05-11 08:36

Posting: # 7004
Views: 5,808
 

 Reference Listed Drug [Regulatives / Guidelines]

Dear All

Please suggest me whether we can do Fasting and Fed BE Studies of same Molecule with two different batches of RLD?

We have conducted fasting pivotal study with one batch of reference product but our client want to go with a different batch of reference product for the fed pivotal study due to unavailabilty of same batch of RLD used for fasting study.

Please advise will the studies be acceptable by the US FDA?


Thanks in advance.


Regards
Kiran
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2011-05-11 09:35

@ kiranActimus
Posting: # 7007
Views: 5,238
 

 Reference Listed Drug

Dear Kiran!

» Please suggest me whether we can do Fasting and Fed BE Studies of same Molecule with two different batches of RLD?

This is a quite common situation; Yes, you can do that.

Cheers,
Helmut Schütz
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kiranActimus
Junior

India,
2011-05-11 09:50

@ Helmut
Posting: # 7008
Views: 5,236
 

 Reference Listed Drug

Dear Helmut

Thanks for the reply.

Is there any guidance for the same or it is just a practice?

Thanks in advance.


Regards
Kiran
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2011-05-11 09:59

@ kiranActimus
Posting: # 7009
Views: 5,264
 

 Reference Listed Drug

Dear Kiran!

» Is there any guidance for the same or it is just a practice?

No guidance I know of. But you already justified it in your first post:
» due to unavailabilty of same batch of RLD used for fasting study.

Of course its desirable to have the same batches (in order to perform a between studies comparison); especially for blockbusters it's unlikely that you get the same batch even after a couple of months. If you are lucky and more than one batch is on the market, try to make a selection matching the first batch (content, dissolution).

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
kiranActimus
Junior

India,
2011-05-11 10:12

@ Helmut
Posting: # 7010
Views: 5,197
 

 Reference Listed Drug

Dear Helmut

Thank you very much for the valuable suggestion.

Regards
Kiran
luvblooms
Senior

India,
2011-06-01 07:30

@ kiranActimus
Posting: # 7045
Views: 5,137
 

 Reference Listed Drug

Dear Kiran

I have a few experience of conducting fast and Fed on different test lot and
EMEA/FDA accepting it.

Reason: We have put batches 2 out of 3 validation batches for the test and proved bio-equivalence and boasted that these studies proved that our formulations are quite consistent.

;-)

Such is life!!!!

Luv

~A happy Soul~
arpit.patel
Junior

India,
2017-04-19 04:04

@ Helmut
Posting: # 17250
Views: 3,328
 

 Reference Listed Drug

Dear All,

I have one concern.

Can we use difference batch of RLD in the single BE study.? Is there any guidance for such information.?

Thanks in advance.

Regards,
Arpit
ElMaestro
Hero

Denmark,
2017-04-19 07:43

@ arpit.patel
Posting: # 17252
Views: 3,309
 

 Reference Listed Drug

Hi arpit.patel,

» Can we use difference batch of RLD in the single BE study.? Is there any guidance for such information.?

I have good experience with it (EU+US+Brazil). There are sometimes good reasons to do it, and sometimes no way around it. I am not aware of specific guidance.

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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.
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