labanya
☆    

2009-02-27 14:28
(5976 d 09:15 ago)

Posting: # 3296
Views: 6,391
 

 Steady state study for Carbamazepine [Study Per­for­mance]

Post reply
Hi,

We are planning to conduct a steady state BE study for carbamazepine extended release tablet of the highest dose. I would like to know:
First will the metabolite be analysed in this case?
Second if any tablet gets missed or the subject vomits after dosing then will the subject be withdrwan from the study?

Thanks
 
Ohlbe
★★★

France,
2009-02-27 19:06
(5976 d 04:37 ago)

@ labanya
Posting: # 3298
Views: 4,826
 

 Steady state study for Carbamazepine

Post reply
Dear labanya,

❝ First will the metabolite be analysed in this case?


For which market are you developing the product ?

Regards
Ohlbe
 
labanya
☆    

2009-03-04 07:26
(5971 d 16:17 ago)

@ Ohlbe
Posting: # 3310
Views: 4,739
 

 Steady state study for Carbamazepine

Post reply
Dear Ohlbe,

❝ For which market are you developing the product ?


The BE steady state study for carbamazepine is for UK submission.

Regards
Labanya
 
UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,694 registered users;
41 visitors (0 registered, 41 guests [including 16 identified bots]).
Forum time: 00:44 CEST (Europe/Vienna)

If I’d observed all the rules,
I’d never have got anywhere.    Marilyn Monroe

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